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