IA #89-08, 8/13/01, "DWPE OF CLASS III DEVICES W/O APPROVED PMA'S OR IDE'S AND OTHER DEVICES NOT EQUIVALENT OR NO 510K" ATTACHMENT REVISED 7/9/04 NOTE: This revision is being issued to revise the alert into the current format and terminology. Changes are bracketed by asterisks (***). TYPE OF ALERT: *** Detention Without Physical Examination (DWPE) *** NOTE: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public. PRODUCT: *** Medical devices (see attachment) *** PRODUCT CODE: *** See attachment *** PROBLEM: Devices are being distributed without a 510(k) or an approved PMA or are not the subject of an IDE. PAF: *** AAP (Approvals) *** *** PAC: 82008 *** COUNTRY: See Attachment MANUFACTURER/ SHIPPER ID: See Attachment IMPORTER'S ID: N/A CHARGE: For Class III device: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1) [Adulteration, Section 501(f)(1)(B)]." For other devices: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a post 1976 device for which a Section 510(k) application has not been determined substantially equivalent or a 510(k) has not been filed [Misbranding, Section 502(o)]." OASIS CHARGE CODE: No PMA No 510(K) RECOMMENDING OFFICE: CDRH, OC (HFZ-323) REASON FOR ALERT: *** Devices listed in the attachment have not been determined substantially equivalent or lack either a 510(k) or a Pre-Market Approval (PMA) for commercial distribution or, alternately, lack an Investigational Device Exemption (IDE). *** GUIDANCE: Districts may detain without physical examination the devices from the firms identified on the attachment to this alert. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 827-7605. PRIORITIZATION GUIDANCE: N/A FOI: Purging between ^ ^ is required KEYWORDS: 510(k), PMA, IDE, Medical devices, devices, Class III devices, Pre-Market Approval PREPARED BY: Ted Poplawski, DIOP, 301-443-6553 DATE LOADED INTO FIARS: Attachment to Import Alert #89-08 Revised 7/9/04 *** Firms and products recommended for DWPE: *** Attachment to Import Alert #89-08 Revised 2/25/04 FIRMS/PRODUCTS RECOMMENDED FOR DWPE Manufacturer Device(s) / Date Added Class ALL COUNTRIES All foreign manufacturers of Hyperbaric Chambers Hyperbaric Chambers Product Code 73CBF -10/29/99 All Countries Little Sentry Junior Infant Breathing Monitor/73FLS 10/30/00 This product was initially recommended for DWPE based on the actions of one firm that was promoting the product in the United States (U.S.). CDRH has become aware that other firms may be shipping this device to the U.S. with the following claims: "The Little Sentry Junior gives parents and healthcare professionals the opportunity to resuscitate babies whose breathing has stopped." "The Little Sentry Junior Monitors the breathing movements of a baby." "Should the breathing movements stop for a period exceeding 20 seconds, a loud pulsing alarm accompanied by a red warning light on the monitor is activated." These types of claims cause the Little Sentry Junior Infant Breathing Monitor to be classified as a device. Firm(s) Product(s)/Code(s) All Countries Ankle Implant Devices containing P.T.F.E./ 87KXC, 87KMD, 87HSN and/or 87MBK - 11/22/00 This product was initially recommended for DWPE based on the actions of one firm that was promoting the product(s) in the United States (U.S.). CDRH has become aware that other firms may be shipping these devices to the U.S. The product is classified as a device, and is of concern when totally or partially constructed of the following: C. Polytetrafluoroethylene(a.k.a. P.T.F.E., Teflon or Proplast) C. Without an approved IDE or PMA, or cleared PMN (510(k). C. The product lacks safety and effectiveness data for PTFE ankle devices specifically, and historical safety issues with PTFE joint replacement devices. All Countries OssaTron - Orthopedic III Extracorporeal Shock Wave System (Model OSA0120 with a serial number less than 45- e.g. "OSA0120 SN *") 76L[][]NS 8/20/01 NOTE: Second-hand devices have been advertised for sale; these devices do not meet the specifications for the approved device. DWPE is recommended for all OssaTron devices unless consigned to the holder of the PMA application. AUSTRALIA Australian Light Therapy Seasonal Affective Disorder Device 108 Forrest St. (SAD Lights) (2/4/92) III Cottesloe, W.A. 6011 Australia Manufactured in China for: "Oradam" latex facial ^ ^ 1/20/95 Medec International MEDEC BioResonance System III 22 Letchworth Centre Ave. 89ISA Salter Point, Australia 2/2/04 FEI# 3004209984 BAHAMAS IHT Limited HIV Oral Test P.O. Box N4361 (aka HIV 1,2 & Subtype O Saliva Test) III Nassau, Bahamas 82---/10/26/99 FEI# 3002835158 Newco Associates HIV Oral Test P.O. Box CB12611 (aka HIV 1,2 & Subtype O Saliva Test) III Nassau, Bahamas 82---/10/26/99 FEI# 3001680610 BRITISH VIRGIN ISLANDS (VG) World Health Diagnostics, Inc. HIV 2 Blood test kit P.O. Box 362, Roadtown (a.k.a. HIVTESTINGKIT) Tortola, VG 82- - - ,57YY99 FEI # 3003016883 5/25/00 Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the U.S. through the mail and may be entered as Asamples@ or for Apersonal use@. The contents may be labeled Afor investigational use@, for Aresearch use@, or Afor export only.@ The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to mis- diagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at 301-827-6201. CANADA (CA) Angel & Company Angelcare Sound - 12/15/98 P.O. Box 879 & Breathing Frequency Knowlton, Quebec, Canada Monitor FEI#: 3002528073 Product Code: 73BZQ ANOGEN (A Division of Yes Biotech HIV-1 & 2 ELISA Laboratories, Ltd.) 82[][][], 57YY[]99 7035 Fir Tree Drive, Unit 23 7/10/01 Mississauga, Ontario, Canada L5S 1V6 FEI #3000972835 3001117636 Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use." The contents may be labeled "for investigational use," for "research use," or "for export only." The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at (301) 827-6201. Anti Aging Solutions Inc. Revitalite Beautifying II #5-1 Westside Drive Soft Light Laser Toronto, Ontario GPI = DE Canada FEI# 3004127431 MANUFACTURED BY: Petra-Electric/Peter Hohlfeldt GMBH & Co. KG Greisbacherstrasse 6 Burgau, Germany CFN: 3002552471 SoftLaser International, Inc Ontario, Canada ^ ^ 7/9/04 FEI #3004604770 NOTE: The Canadian firm was issued a Warning Letter from CDRH on 3/25/2004, warning them to discontinue marketing these devices in the U.S. There is currently no evidence these devices are marketed in the U.S. by the manufacturer. Districts should be aware that although the correct product code for this type of product is 89NHN (Lamp, Non-Heating, for Adjunctive Use in Pain Therapy) the product has previously been miscoded as 95L 22 (Laser Products/Laser Product for Non-medical Use). Aqua Sole Company Ltd. Eye Mask (or Eye Masque) 27 Passmore Avenue, Unit #1 Scarborough, Ontario M1V 4T4 Canada MID #XOAQUSOL27SCA A & T Company HIV 1/2 Saliva Test Kit 43 Vanity Crest (aka Easy Home Test or easyhivtest) Richmond Hill, Ontario Product Code: 82[][][], 57YY99 L4B 4E5 Canada 9/14/00 FEI# 3003109775 Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use." The contents may be labeled "for investigational use," for "research use," or "for export only." The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at (301) 827-6201. BioChem ImmunoSystems, Inc. BioChem SELECT-HIV Kit 10900 Hamon St. Product Code: 57YY99 Montreal, Quebe 7/27/98 c Canada FEI #1000229412 Biotronix 2000, Inc. NeedleSafe, all models 2185 Michelin including NX3000, NX2000, Laval, Quebec NX1000, NX5000 SDS; 80KDB Canada H7L 4S2 & FEI# 3002129220 Sharpes Container sold with Model NX5000 SDS and alone; 80MMK - 8/19/98 THE FOLLOWING FIRM (AND PRODUCTS) WAS NOTED ON THEIR INTERNET WEB SITE OFFERING FOR SALE VARIOUS UNCLEARED MEDICAL DEVICES TO CITIZENS OF THE UNITED STATES. THE DEVICES APPEAR TO PREVENT PREGNANCY AND DISEASE TRANSMISSION, WHICH REQUIRE MARKETING CLEARANCE AND MAY NOT BE LEGALLY MARKETED IN THE UNITED STATES (US) WITHOUT SUCH CLEARANCE. THE DEVICES ARE CONSIDERED ADULTERATED UNDER SECTION 501(f)(1)(B) AND MISBRANDED UNDER SECTION 502(o) OF THE ACT AND MAY BE IN VIOLATION OF TITLE 21 OF THE UNITED STATES CODE, SECTION 331(a) AND 331(d). BIRTHCONTROL.COM LEA SHIELD (BARRIER) 85LLQ 1269 56TH. STREET #18037 ANTYCONDOM 85LTZ DELTA, BC. CANADA C4L2M4 UNISEX CONDOM 85MEE FEI# 3002983254 DENTAL DAM Correction 5/2/00 OVU-TRAC LADYCOMP AND BABYCOMP COMPUTERS OVES CONTRACEPTIVE CAP Persona Contraceptive Monitor 85MEE 5/8/01 Class III Device (OTHER ADDRESSES) 188-3854 Gordon Dr. Kelowma, BC, Canada FEI #3001066002 BOX 25006 MPPO KELOWMA, BC. CANADA FEI # 3001159362 Comptronics Devices Limited Oasis Cranial Electrotherapy Stimulator 9008-51 Avenue (CES) Edmonton, Alberta 84 JXK Canada 6/29/00 FEI # 3003046588 Fidelity Electronics of Canada (Shipper) 5/6/94 5696 Ambler Drive Mississauga, Ontario, Canada L4W 2K9 MID# XOFIDELE5696MIS Health Care Products, Inc. Wipeout Long Life Activated N/A 165 Matheson Blvd. E., Suite 8 Dialdehyde Mississauga, Ontario, (4/27/93) Canada L4Z3K2 ID# XOHEACAR165MIS Health Light, Inc. Seasonal Affective III P.O. Box 3899 Station C Disorder Device Hamilton, Ontario L8H 7P2 (SAD Lights) Canada (2/4/92) Ind Diagnostics Inc. New Choice Pregnancy III 1629 Fosters Way Test Kits Delta, British Columbia 75LCX V3M 6S7 9/26/03 Canada FEI #3003148151 Repacker/Relabeler: Unique Design Inc. 5773 Ferrier, Suite 206 Montreal, Quebec H4P 1N3 Canada FEI #3003541998 International Biotech Corporation HIV 1/2 Blood Test Kit #616, 10216-124 Street (aka V-Scan HIV-1 & HIV-2) Edmonton, Alberta, T5N 4A3, Canada 82[][][], 57Y[][]99 FEI# 3002848449 11/9/99 J.K. Orthomedic, Ltee. LARS (Ligament Advanced a.k.a. Kirschner Canada Reinforced System) 1755 St. Regis 210 PRODUCT CODE: 87LML Dollard-des-Ormeaux 10/13/95 Quebec, Canada H9B2M9 Medevice Inc. Bio-Mate Spinal Catheter 5080 Timberlea Blvd. 2/25/93 Unit 11, Mississauga Ontario, L4W 4M2 Canada XOMEDINC508OMIS Medionics International, Inc. QC Transfer Sets Plant: 114 Anderson Avenue 12/15/92 Markham, Ontario L6E 1A5 Canada MID# XOMEDINT114MAR Office: 1271 Denison Street Suite 4950 Markham, Ontario L3R 4B5 Canada MID# XOMEDINT4950MAR Northern Light Thechnologies Seasonal Affective Disorder III 3070 Brabant-Marineau St. Device (SAD Lights) St. Laurent, Quebec I4S 1K7 (2/4/92) Canada Nordion International, Inc. Validose Dosimetry System II 447 March Road 8/17/93 P.O. Box 13500 Kanata, Ontario Canada K2K 1X8 MID# XONORINT1350KAN Preferred Medical Products Spinal anesthesia III 3280 Schmon Parkway trays containing Thorold, Ontario L2V 4Y6 tetracaine hydrochloride Canada for use in the pediatric population ID# XOPREMED3280THO Continuous Spinal Anethesia III Trays (non-pediatric) (3/5/93) Epi-Spinal Tray-Reorder #2002 III Epi-Spinal Mini Kit-Reorder #2005 III (7/30/93) Seville Marketing Discreet HIV Test III 3017 Mountain Way 82---/10/26/99 P.O. Box 16047 North Vancouver, BC, V7J 2R0 Canada FEI# 3002764311 Sudor, Inc. Ground Zero, P.O. Box 383 Ground System and Collingwood Ontario methods for organisms Canada L9Y 3Z7 (Ground Zero Grounding Device) FEI # 3002828315 Product Code 84- - - 10/20/99 * Tri Hawk International Histoacryl Tissue III 1570 Rue Bane Adhesive Montreal, Quebec, Canada, H4L 4M6 5/11/93 *(Shipper for B. Braun Melsungen AC.) Ultrasoft Laboratories Contact Lenses (all types) II 8855 Northbrook Court 2/9/93 Burnaby, British Columbia V5J 5G1 Canada ID# XCULTLAB8855BUR ID# XCULTSOF4025BUR Yocan Medical Systems Inc Histoacryl Tissue Adhesive (MAY ALSO BE III 4 Spirea Ct. IDENTIFIED AS BIOLOGICAL GLUE) Thornill, Ontario, Canada 84KGG L3T 2W1 79MFI FEI #1000189357 (NOTE: PRODUCT HAS ALSO BEEN CODED AS A DRUG UNDER 66V--99) 12/17/98 CHINA, PEOPLES REPUBLIC Beijing Wantai Biological HIV 1 & 2 Rapid Test Kit III Pharmacy Enterprise Co.Ltd. 82- - - No. 7 Chuangxin Rd. 57Y- - 99 Technique Garden of Changping 2/25/04 Beijing, China FEI# 3003950825 Guanzhou HuaNan Medical Positive/Negative Pressure Apparatus Co., Ltd. (MFR.) Integrated Computer Control 212 Xingang W. Rd. Augmented Sequential External Guangzhou, 510300, China Counter-Pulsation Devices FEI# 3001403711 Prod. Code 89[][][] 2/24/98 Shipper for Guanzhou HuaNan: Shandong Medicines & Health Products Import/Export Corp. 16 Baoding Road Qindao, China FEI# 3000246908 China National Agricultural Machinery Universal Massage Shenzhen, China Apparatus MID #CNCHINATSHE 11/30/94 Chongqing Bashan Instrument Factory TDP Special Electromagnetic 83 Shi Xin Road Therapeutic Apparatus Chongqing, PRC 630039 80ILY FEI# 3000983373 8/19/97 Doo Jung H.K. Limited Pap Smear Brushes (may be II Kwan Lan Town shipped as cosmetic brushes Tai Wo Village or may be brush head only. Shenzhen, China 6/8/93 ID#: CNDOOJUNSHEN Hsin Ten Health and Wealth Industry (HEFEI) Co. Ltd. 4/24/00 Hot House YS-50 FIR 669 Changjiang West Road Health Builder Heifei, China 89ILY FEI # 3002989940 The Gatoson Holdings, Ltd Pulse Generator, Pacemaker III One International Finance Centre Implantable 18th Floor 74DXY 1 Harbour View Street, Central 4/14/03 Hong Kong, China FEI #3003985965 CZECH REPUBLIC Gel-Med International ***DILAPAN Hygroscopic III spol s.r.o. Cervical Dilators V Cibulkach 51, DILAPAN-S Hygroscopic 150 00 PRAHA 5 Cervical Dilators Czech Republic 6/26/96 FEI# 1000573518 85MCR Dilapan-S III (Cervical Dilator) 85L0B 2/17/04 ***(DILAPAN Hygroscopic Cervical Dilators may be identified as being manufactured and distributed under the label ^ ^") and DILAPAN-S Hygroscopic Cervical Dilators may be identified as being distributed under the label "FEMA INTERNATIONAL") and shipped by:*** ***Shipper: Kamedico Health Care Products, Inc. 1759 West 3rd Avenue Vancouver, B.C., Canada V6J 1K7 FEI# 1000371924 MID# XCKAMHEA1759VAN ***Be aware that the U.S. manufacturer of the DILAPAN cervical dilators is ^ ^ who is presently under injunction since these devices were manufactured in the absence of a valid supplemental PMA and contrary to applicable good manufacturing practices (GMPs).*** DENMARK Ambu International A/S Ambu Cariopump ACD Resuscitator SDR. Ringvej 49 4/29/94 2600 Glostrup Denmark MID #DKAMBINT215GLO FINLAND Labsystems OY Tetanus IgG EIA Kit II Pulttitie 8 P.O. Box 8 00880 Helsinki, Finland ID#: FILABOY8HEL (6/4/93) FRANCE Burnet Laboratoire Sterile Surgical Gloves III Pharmaceutique Av. Georges Denos, B.P. 61 72403 La Ferte Bernard, France Chauvin Opsia S.A. Oxane, Purified Silcone Oil III Rue Max Planck Bp 711 (Intraocular Fluid for Retinal 31683, Labege, France Reattachment)/86LWL FEI #3002558775 5/31/01 ELA Medical Chorus RM cardia pacemaker model 7034 III 98-100 Rue Maurice Arnoux (9/9/92) 92120 Montrouge, France Chorus II cardia pacemaker Model 6234 III (9/9/92) Laboratoires Eurosilicone All Devices III 21, rue Francis Combe 12/28/94 95000 Cergy Pontoise France MID# FRLABEUR21PON Laboratory Nycomed Polyvinyl Alcohol Foam III Ingenor SA, 25 Quai Particles PVA Foam) and de la Gare-C.E. Balloon Catheters No.19 F-75644 Paris Cedex 13 France LARS LARS (Ligament Advanced 5 Rue de La Fontaine Reinforced System) Arc Surtille PRODUCT CODE: 87LML France 21560 10/13/95 Medical Z, S.A. All Scar Management BP 39, 55, Rue De L'Eglise Gel Products (Medigel Z) 61110 Remalard 79MDA France 11/27/96 FEI #1000656612 MID #FRMEDSA55REM Opsia Laboratories All 100% Perflourodecalin III 10, Avenue De L'Europe DK Lines Ramonville-Saint-Agne France Orthomed Ligastic artificial 256 Rue Vignes Dardelain ligament(s) 21160 Marsannay LaCote PRODUCT CODE: 87LML Dijon, France 10/13/95 ProCytech S.A.S. Outline Ultra III 4 Rue Jacques Monod A Bioresorbable Polyacrylamide Technopole Montesquieu Filler for Soft Tissue Martillace, France F-33650 (Facial Augmentation) FEI # 3003417752 8/26/03 SAPP #4 Rue Cozette Audiokinetron Device 8000 Amiens Product code 76MGE France (3/29/94) MID #FRSAP4AMI TH SA Presso Dren 207: Pressure Therapy Apparatus 32, Chemin de la 89HTM Violette 8/2/01 31240 L'Union France FEI #3003338887 Tomatis Electronics Electronic Ear, or any device 56 Rue Des Batignolles labeled or marked for auditory 75017 Paris training, auditory integration, France or behavioral improvement. FEI #3000190157 2/5/97 MID #FRTOMELE76PAR AND PRODUCT CODE 84GWJ Tomatis International 2/5/97 6, Place de la Republique - Dominicaine 75017 Paris France FEI #3000190169 MID #FRTOMINT6PAR GERMANY Aesculap Aktiengesellscraft Heifetz Skull Perforator Drill (only) III Postfach 40 (11/5/92) D-7200 Tuttlingen, Germany B. Braun Melsungen AC. Histoacryl Tissue III Carl Braun Strasse 1 Adhesive Melsungen, West Germany ID# DEBRAMEL1MEL *Beltex Histoacryl Tissue III C.P. 222 Adhesive St. Sulpice, Quebec, J6K 3JO (5/11/93) ID# XQBEL222STS *(Shipper for B. Braun Melsungen AC.) (HEADQUARTERS) Binder International Ondamed System Regulation Lack of 510(k) GmbH & Co. (Biofeedback Device) Approval Otto Hahn Strasse 19 84HCC Herrenberg-Kuppingen 04/29/03 Germany FEI #3003752197 Binder GmbH P.O. Box 102 Tuttlingen Germany FEI #3003765734 Binder GmbH Kurzeller Str. 18 Schwanau, AL Germany FEI #3003775444 Kendall Germany CURITY Continuous III CDK Holding GmBH Spinal Anesthesia Raffineriestr, 8 Tray COSPAN Continuous III Spinal Anesthesia Tray COSPAN Pediatric III Spinal Anesthesia Tray CURITY Pediatric III Continuous Spinal Anesthesia Tray Leibinger GMBH Total Joint or Condylar protheses for III Schutzenstrabe 5-7 the Temporomandibular joint (TMJ) D7200 Tuttlingen (4/16/93) Germany, Federal Rep. of ID# DELEIGMB57TUT U.S. Distributor:^ ^ Morcher Gmbh Aniridia Implant III Kapuzinerweg (i.e. modified Intraocular lenses D70374 Stuttgart or capsular tension rings)/86MRJ Wurttemberg-Baden 5/31/01 Fed Rep of Germany FEI #1000447964 Capsular Tension Rings (only those III manufactured prior to 12/11/03) 86MRJ Aniridia Implant Devices III (Modified Intraocular Lenses) 86HQL 2/9/04 Novafon Elektromedizinche Therapeutic Massagers: Gerate GmbH (aka Novafon GmbH) Novafon SK1 Sound Stuttgart, W. Germany Wave Appliance III ID# DENOVELE7000STU Nostrafon SK2 Sound III or DENOVGMB7000STU Wave Appliance Medi-pol, (magnetic field III therapy attachment used as an accessory device with Nostrafon unit) Rheinmagnet, Inc. Magnetic Devices Germany No classification name, FEI #1000490604 number, or regulation citation MID #DERHEINCUNK 2/29/96 Team Ver Packung Silicone Oil III Muhlen Koppel 2 for Opthalmic Ascheberg-Trentrade, Use (Sterile) Germany, Federal Rep. of GREECE (manufacturer) PAP-IMI Ion Magnetic BioElectroDynamics Conductor Device (aka Z Electrodynamics; Unclassified -- Dr. Panagiotis (Panos) T. Pappas, owner) industry code 84 (no known street address) 1/13/03 Athens, Greece FEI #3003891272 (importer of record) Bio-Energy Services, Inc. 18727 Ventura Blvd. Tarzana, CA 91356 FEI #3003668912 HONG KONG Asia Unlimited The Shealy RelaxMate (aka RelaxEase) Hong Kong 86H0Y FEI #3002165857 8/27/98 Automatic Manufacturing Ltd. (Mfr) Shealy Relaxmate Kiwuntong, Hong Kong Glasses MID# HKAUTMANKIW 5/6/94 Azad International (HK) Limited WhisperXL mini sound II 33 Canton Road amplifier (behind the ear TRW 1, Room 2103 hearing aid) Kowloon, Hong Kong 12/21/94 Century International Hothouse FIR Health Lacks 510(k) Development Ltd. Builder Flat Rm 701 89IOB Sino Center 582-592 11/26/01 5825 Nathan Road Mongkok, Hong Kong FEI# 3003381112 and Hsin Ten Health and Wealth International Inc. 669 Changjiang West Road Heifei, China FEI# 3002989940 Doo Jung H.K. Limited Pap Smear Brushes (may be II 21-D Broadway shipped as cosmetic brushes 12/F Mei Foo Sun Chuen or may be brush head only. Laichikok, Kowloon 6/8/93 Hong Kong ID#: HKDOOJUN21LAI Soft Lines Limited Emjoi Body Fat Monitor AP-30 Lack of 510(k) 512 North Tower (Body Composition Analyzer) Approval Concordia Plaza-1 74MNW 1 Science Museum Road 8/26/03 Tsimshatsui East Kowloon, Hong Kong FEI #1000383100 Sundries Network OC's HIV-1/2 Antibody III International Limited HIV-1/2 Whole Blood Flat B, 4/F, One Step Test Kiu Fu Commercial Building 82[]--[][], 57YY[]99 300 306 Lockhart Road 9/19/01 Chai Wan, Hong Kong FEI# 3003433783 Note: HIV diagnostic test kits are Class III device within the meaning of section 513(f)(1) of the Act and are regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the U.S. through the mail and may be entered as "samples" or for "personal use." The contents may be labeled "for investigational use," for "research use," or "for export only." The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at (301) 827-6201. INDIA International Medical Devices Freeman Universal III 17 Industrial Estate, Palam Rd. Intraocular Lenses Bombay, India (IOL) Anterior Chamber (Optional posterior chamber Style Code: IMD-AC-FA 7/6/92 Shah & Shah Intraocular Intraocular Lenses III Lens (Pvt) Ltd. 86HQL 2 Russell Street 4/10/95 H.D. Road, Joka 743512 Calcutta 700 071, India MID: INSHASHA743CAL FEI: 1000327725 ISRAEL Zer Science Ltd. HIV I+II Class III aka Zer Ltd. One-Step Test aka Zer Hitech 7/9/98 Shatner Center 3 82[][][], 57YY-99 Jerusalem, Israel *alias 8/23/01 FEI #3000168281 NOTE: Several FDA districts have encountered shipments of unapproved HIV diagnostic test kits invoiced and labeled for "research use only" or "investigational use only", and some of the kits were unlabeled. HIV diagnostic test kits are Class III devices within the meaning of Sec. 513(f)(1) of the Act and are regulated by CBER under the current Intercenter Agreement between CDRH and CBER. Investigations by FDA revealed that the unapproved HIV diagnostic test kits were intended for commercial distribution, not for "research" or "investigational" uses as invoiced. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. Districts encountering shipments of the unapproved HIV diagnostic test kits should contact the CBER Import/Export Team at (301) 827-6201. ITALY Biorem s.r.l. SkinMaster Micro- Lacks 510(k) Via Angrisani 18/A dermabrasion products 84043 Agropoli (SA) 79--GFD/79--GEX Italy 1/2/02 FEI# 3003494110 M.E.D.I.Co Italia Pacemaker (Phymos ADV/VDD-M) III Medical Electronic Devices (12/08/92) International Co. Via Pitagora, 15-35030 Rubano (PD) Italy MID# ITMEDELEISRUB Sa Mas S.r.l. Attila Evoluzione Electrical II Via Tarlazzi 5 Stimulation device 31014 Colle Umberto 84GZJ Umberto, Italy 4/12/01 FEI# 3003238077 S.M.E.I.srl Sculpture Ultrasonic Aspiration Device (Surgical Medical Aesthetic (Sculpture Ultrasound Wave Liposculpture) Supplies) Via F. Negri 15 Product Code: 85MGI 15033 Cassale Monferrato 1/22/99 Alessandria, Italy FEI #3001811866 JAPAN Daito Electric Machine Massagers, Muscle Stimulators III Industry Co., Ltd. 84GZJ, 89ISA, 89IPF, 89MPH 9-11, Showa-Cho 89NGX Higashi, Osaka, Japan 04/29/03 FEI #6878 Fuji Latex Co., Ltd. Wrinkle Chapeau Condoms II 19-1, 3-Chome (7/20/93) Kanda Nishiki-Cho, Chiyoda-Ku Tokyo, Japan ID# JPFULAT191CHI Fuji Medical Instruments "New Health Club" III Mfg. Co., Ltd. Low Frequency 5-521 Nipponbashi Therapeutic Apparatus Naniwa-Ku, Osaka, Japan Type C, Model HC-32 MID# JPFUJMED5521OSA (8/13/93) Hirayama Manufacturing Corp. Sterilizer, autoclave 2-16-16 Yushima, Bunkyo-Ku 75LXG Tokyo 113 9/17/98 Japan FEI# 1000197696 Kyoto Daiichi Ammonia Checker II III Kagaku Co., Ltd Blood Ammonia Checker System 57 Nishi Aketa-cho Model AA-4120 (9/9/92) Higashi Kujo Minami Ku Kyoto 601, Japan Maramunji Sangyo Co., LTD Infant Heel Warmers 17-11-3 Ishimaru Infant Crib Warmers Mino-Shi 12/27/94 Osaka 562, Japan Nippon Germanium Laboratory Co., Ltd. Germanium Pellets 2-11-9 Kasuga, Shizuoka City Bandages III Shizuoka, Japan 5/20/96 MID# JPNIPGER2119SHT FEI# 1000548833 Sanwa Health Co. Ltd Germa Knee Sports Wrap III 39 Kamisekerya-sho Germa Adhesive Bandages III Murasakamo, Kita-Ka Kyoto, Japan KOREA Choyang Medical Co., Ltd. Choyang Dana CY5000 Physical Therapy Table III 45-1 Woebu-Ri Choyang Dana CY2000 Muscle Stimulator III Kunbuk-Meon Choyang Dana CY1000 Muscle Stimulator III Kumsan-Kun, Chungnam Choyang Dana JO EUN A CIM(Deluxe Heating Pad) III Republic of Korea Choyang Dana JO EUN A CIM(Regular Heating Pad)III FEI #3003788127 89JFB, 89MPH, 89IRT 4/23/03 Choyang Medical Co., Ltd. 398 Chujung-Ri Chubu-Myun Gumsan-Goon Choong-Nam Republic of Korea FEI: 3003244884 Hesung Medical Supply Scalp Vein Sets II 517-4 Sangdaewon-Dong Infusion Sets II Seongnam City, Seoul, Korea Unis Medical Electronics Heparin Lock (PRN) II Co., Ltd. Protected Needle II Rm. 508, Dae Kwang Bldg 7-15 Adapter (PNA) Nonhyun-Dong, Xangnam-Ku IV In-Line Connector II Seoul, Korea Multiple Sample Luer II Adapter ID# KRUNIMED715SEO (3/5/93) LUXEMBOURG Biotech Industry S.A. New Fill, Poly Lactic Implant 212 Bernard Haal (Dermal Implant for Aesthetic L1711, Luxembourg Use)/79LMH FEI #3003165206 4/9/01 MALAYSIA Alang Bidara Industries Latex Patient I Sdn Bhd, Lot 2574, Examination Gloves Kampong Olak Lempit 80LYY, 80FMC Kuala Langat 9/4/96 42700 Banting, Selangor Darul Ehsan, West Malaysia FEI# 1000565458 MID# MYALABID2574KUA MEXICO (MX) DRA. Olga Z. de Kleiman Little Sentry Junior 175-101 Cuernavaca Infant Breathing Monitor Col. Condesa, Mexico City, 73FLS Mexico 6/29/00 FEI # 3002589842 MONACO (MC) 1-Minute-Test Ltd HIV 1/2 Whole Blood Test Kit 13 Bd Princess Charlotte 82[][][], 57Y[][]99 Monte Carlo, Monaco 98000 11/9/99 FEI # 3002848460 PAKISTAN (PK) Gogi Enterprises Circumcision Clamps P.O. Box 1367 85H- - FX Sialkot, Pakistan 5/17/00 FEI # 1000627636 Dar Expo P.O. Box 356 Fatima Jinnah Rd. Small Industries Estate Sialkot, Pakistan FEI # 3001348390 SINGAPORE (SG) Genelabs Diagnostics PTE LTD Helico Blot 2.0; 83LYR 85 Science Park Drive, #04-01, HEV IgM ELISA; 83--- & The Cavendish, OraScreen HIV Rapid Singapore Science Park Test Kits; 57YY99 Singapore 8/13/97 FEI #1000436598 OSIM International PTE, Ltd. Blood Pressure Monitors, III 240 MacPherson Road Massagers, Muscle Stimulators #07-01 Pines Industrial Bldg. 74DXN, 74DXQ, 84GZISA Singapore 89IPE, 89MPH, 89NGX FEI #3000992569 04/29/03 SOUTH AFRICA (ZA) Anytestkits HIV 2 blood test kit Sunnyside 82- - - , 57YY99 Republic of South Africa 5/25/00 FEI # 3003016880 Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER under the current intercenter agreement between CDRH and CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the U.S. through the mail and may be entered as Asamples@ or for Apersonal use@. The contents may be labeled Afor investigational use@, for Aresearch use@, or Afor export only.@ The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to mis- diagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at 301-827-6201. Ageless HIV 1/2, HIV 2 subtype O, Box 29054 serum, plasma or whole blood Sunnyside test kit 0132 Republic of South Africa (aka HIV/AIDS home test kit) FEI# 3003010115 82[][][], 57Y[][]99 1/29/01 M A Meyer HIV 1/2, HIV 2 subtype O, Box 29054 serum, plasma or whole blood Sunnyside test kit 0132 Republic of South Africa (aka HIV/AIDS home test kit) FEI# 3003010115 82[][][], 57Y[][]99 1/29/01 Sallamander Concepts HIV 1/2, HIV 2 subtype O, Box 29054 serum, plasma or whole blood Sunnyside test kit 0132 Republic of South Africa (aka HIV/AIDS home test kit) FEI# 3003134155 82[][][], 57Y[][]99 1/29/01 Note: HIV diagnostic test kits are Class III devices within the meaning of Section 513(f)(1) of the Act and are regulated by CBER. The unapproved diagnostic test kits claim to detect HIV antibodies in blood or saliva and provide results in the home in 15 minutes or less. The test kits are imported into the U.S. through the mail and may be entered as "test kit," "samples" or for "personal use." The contents may be labeled "for investigational use," for "research use," or "for export only." The test kits could present a serious hazard to the public health, including possible HIV transmission to partners and delayed access to medical care due to misdiagnosed false negative tests. If entries are encountered, contact CBER Import/Export Team at (301) 827-6201. SPAIN (SP) Sedecal, S.A. X-Ray Systems (All)/90IZF, 90IZG (Sociedad Espanola de Electro- 90IZH, 90IZI, 90IZJ, 90IZL, 90JAA medicina y Calidad, S.A.) 90JAB, 90JAC, 90KPQ, 90KPR Pelaya 9, Poligono Industrial Rio 7/25/01 de Janeiro, Madrid E-28110 Spain FEI #3002495042 SWEDEN (SE) Lic Care, AB BD5000 Optima Birthing Bed (10/27/92) II Svetsarvagen 20 BD6000 Optima Birthing Bed (10/27/92) II Solna, Sweden Postal Address: LIC Care, AB 5-17183 Solna, Sweden or LIC Rehab Care AB Box 8164 S-163 08 SPANGA, Sweden Q-Med AB Perlane Sodium Hyaluronic Acid & Seminariegatan 21 75LZX, 89LZX, 89MOZ, 80LDQ SE-752 28 Uppsala, Sweden 6/3/02 FEI #3003591725 Scandicare Products AB All devices Depagaten 2, Box 34 Product codes: 85HFW, 79HXD S-33400 Anderstorp, Sweden 11/21/95 FEI# 6891 MID# SESCAPRO24AND SWITZERLAND Bilimed AG Belimed Washing Machine Model SM 700 Ch-5608 (3/5/92) III Stetton Belimed Scope Washing Machine Model Switzerland SME 2000 (3/5/92) III Belimed Washington Machine Model SM 1000 (3/5/92) III Compex, S.A. Compex 2 Iontophoresis (Product Code=89EGJ) Chemin Du Devent 3/1/99 CH-1024 Ecublens Switzerland FEI# 3002601983 Corange International Ltd. Elecsys HBsAg Hamilton Cham Branch Immunoassay Kits Hinterbergstrasse 9, 11/26/97 Postbach 5146 PRODUCT CODE Cham, Switzerland 6330 83L[][]OM FEI#1000326892 HAMO AG Endoclean 2000, and Decontaminating II Reinigungs-Hyglenetechnik Machines Models LS-850, LS-76, DW/T-216 Bielstrasse 76 (1/30/92) 2542 Pieterlen/Biel Switzerland Health Angel, Gmbh Evoked Response Electrical Obergass 3, CH-8193 Stimulator Eglisan/Zurich, Switzerland 84G[][]WF FEI #3002821759 5/25/01 Home Art and Sales Zepter Cosmetics Electro- Services AG Acupuncture Device/73BWK Sihleggstrasse 23 12/3/03 CH 8832 Wollerau Switzerland FEI #3003348812 Minimally Invasive Products, GmbH Orbasone TM, aka Kreuzlingen, Switzerland Orbasone Therapeutic Vibrator) FEI # 3003046204 and Ossanol TM, aka (Ossanol Therapeutic Vibrator) 89IRO - 6/29/00 TAIWAN, ROC ACUTE IDEA CO., LTD. Pacifier Thermometer TAIWAN, R.O.C. 3/9/94 BeautiStyle Int'l Corp. Ozone Clean & Beauty Massager 17 Hu Ja Rd., 1f, Lane 149 89I[][]RO Taipei, Taiwan 4/29/02 FEI# 3003362156 Distributed by: ^ ^ Trade Name: Paci-Temp Inno-Health Technology, Inc. Aculife TENS Device III c/o 21SO Consultants, Inc. 84GZJ Att: Micharl Lu 2/17/04 7/F, No. 86, Guoxing Road Taipai City, Taiwan, 108, China FEI# 3004443805 ^ ^ Trade Name: Lumiscope Baby Therm WINTEK MICROCIRCUIT CORP. Pacifier Thermometer Taipei, Taiwan, R.O.C. 3/9/94 Distributed by: ^ ^ Trade Name: Dubby ^ ^ Trade Name: Lumiscope Baby Therm TAIWAN SHINING YOUNG TRADING Pacifier Thermometer Co., Ltd. Taipei, Taiwan R.O.C. 3/9/94 Trade Name: Knoble Distributed by: ^ ^ Trade Name: Lumiscope Baby Therm Chipper-Tech Co. Brainwave Synchronizer No. 19 Lane 53 Shwanglien St. 9/9/94 Taipei, Taiwan Importer/Consignee: ^ ^ or ^ ^ Kung's Medical Instruments LYM -03-Terminator Mini Electrical III Company, Ltd. Syringe Needle Destroyer (2/1/93) P.O. Box 55-1620 Taipei, Taiwan, ROC T.A. Yu Chanc Industrial Co., Ltd. Sun Eeze (fitsrite) 299 Nan Yang Road protective eye wear Seng Yaun, Taiwan ROC (10/14/94) UNITED KINGDOM Abby TENS TENS Elite, Profile TENS, III 46 Cambridge Street TENS N Tone, TENS Elite Dual Wolverton Lead, Lady TENS, 804-OB Milton Keynes, England Obstetric TENS Unit (Abby TENS) MK12 5AH 84G[][]ZJ FEI# 3004022293 5/15/03 Body Clock Health Stimplus electronic acupuncture II Care Ltd. device/73BWK 108 George Lane 5/31/01 South Woodford London, England FEI# 3003267895 TENS Elite, Profile TENS, III TENS N Tone, TENS Elite Dual Lead, Lady TENS, 804-OB Obstetric TENS Unit (Abby TENS) 84G[][]ZJ 5/19/03 Life-Energies Ltd. Training Materials 3/13/01 The Coach House, The Avenue Introductory Training Odstock, nr. Salisbury Level 1 Training United Kingdom SP5 4JA Level 2 Training FEI# 3003080568 Eliminating Electromagnetic Stress From Your Life Skenar (Self-Controlled Energo-Neuro-Adaptive Regulator) The NEW Life-Energies' Skenar 97.4 The (fully automatic) Pocket Skenar Large Energiser Healing Blanket Medium Energiser Healing Blanket Small Energiser Healing Blanket Cell-O-Matt Kit ` Computer Clear PRODUCT CODES 84JXK (Skenar and Training Materials) 84[][][] (Healing Blanket and Cell- O-Matt) The articles are considered adulterated in that they appear to be class 3 devices and do not have an approved application for premarket approval. The articles are also considered misbranded in that it appears a notice or other information respecting the device was not provided to the FDA as required by Section 510(k). Medical Wire & Equipment Co. Transwabs (MW169C, (Bath) Ltd. MW172PT, MW172CT, Corsham, Wiltshire, England MW174P, MW175C) UK SN13 9RT Theater Pack, Virocult, MID# UKMEDWIRCOR Chlamydia Transwab, Strip tests (Beta, Pro-, Pyo, Gram, and Indo-Test), Micro Ring (XV, AC, AN, and Yeast ID) 1/13/95 Unipath Ltd. Persona Contraceptive Monitor Norse Road 85MEE Bedford, United Kingdom Class III device FEI# 3002808416 2/5/02 Shipped by: The Garden Pharmacy 119 Long Acre London, United Kingdom FEI #3003110891 UKRAINE (UA) Science Production Centre Viatec Arbor Test-Microscope for Erevanska Street 31/1 Regulation of Pregnancy Kiev, Ukraine 03087 75LCX and 88GJY FEI# 3003018884 3/16/01