IA #80-06 - 9/28/92, "Automatic Detention of Fraudulent and Deceptive Medical Devices", Attachment - Revised 2/10/04 TYPE OF ALERT : Automatic Detention PRODUCT : Fraudulent and deceptive medical devices (See Attachment) PRODUCT CODE : 80------- HARMONIZED CODE : N/A PROBLEM : Distribution of medical devices determined to be fraudulent and deceptive due to unsubstantiated labeling claims (DVFR) PAC FOR COLLECTION : 82002 COUNTRY : All importing countries (multiple, 999) MANUFACTURER/ SHIPPER : All MANUFACTURER SHIPPER I.D.# : N/A IMPORTER'S I.D.# : N/A CHARGE : "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device which is misbranded in that its labeling is false or misleading" [Misbranding, Section 502(a)]." RECOMMENDING OFFICE : CDRH, Division of Compliance Operations, Regulatory Guidance Branch, (HFZ-323) REASON FOR ALERT : Devices listed in the Attachment are misbranded due to false or misleading labeling claims INSTRUCTIONS : Automatically detain all designated devices from importation into the United States. FOI : No purging is required KEYWORDS : Fraudulent, deceptive, misbranded, devices PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553. Attachment to IA #80-06 Revised 2/10/04 ARTICLE CLAIMS All Intraocular Lenses Manufactured Counterfeit PMMA intra- in Pakistan (PK) ocular lenses. Packaging 86H[][]QL may show manufactured by Class III Device Rayner's Ltd., U.K. 10/5/01 Amulets (ornamental articles worn Therapeutic claims of next to the body, as on a necklace, physiological capabilities bracelet, or carried in pockets), i.e.,"shielding "alignment", on the body magnets etc. Small, polished, circular "dots" Any reference to acupressure, to be used singly (stuck on the or meridian therapy to achieve body), or grouped (such as on an a therapeutic effect. insole to be worn in the shoes). Quartz Crystals, usually worn Any therapeutic capabilities as a necklace or body jewelry. derived from the quartz or its emissions (energy). Pyramid Tents (various sizes) Any therapeutic claims related to concentrating the "power" of the sun, when properly aligned magnetically, to achieve any beneficial effect. Therapeutic Blankets or Therapeutic claims such as mattresses usually filled with blood pressure or lambs wool. any physiological action. Includes claims of general well being. "Roller" therapy products. Any claims of therapeutic These are banks of rollers capability including or cones to be drawn over parts references to acupressure. of the body, or to massage the feet. Ear rings and/or Ear molds Claims related to appetite control using acupressure points on the ear. "Radio-active" earth filled Any therapeutic claims about pads and pillows. the healing properties of radio-active earth. Miniature bar magnets to be Any therapeutic claims of used singly or in groups, used resurgence in the body due in mattress pads, bandages to energy induced by magnets. to promote healing, etc. Magnetic Band, Mens Relief of pain, stiffness and soreness Magnetic Band, Womens Relief of pain, stiffness and soreness Magnetic Knee Support Relief of pain and stiffness Magnetic Lumbar Support Relief of Stiffness and pain in muscles Magnetic Patch, 5/Strip Relief of pain, stiffness and soreness Magnetic Bead Bracelet Relief of pain, stiffness and soreness Magnetic Steel Necklace Relief of neck, shoulder and back pain and stiffness; improvement of circulation Magnetic Men and Lady Relief of pain, stiffness and SS Band soreness Magnetic Twist Bead Bl. Relief of pain, stiffness and soreness Magnetic Twist Relief of neck, shoulder and Bead Necklace back pain and stiffness; improvement of circulation Magnetic Wrist Support Relief of pain, stiffness and soreness Magnetic Life Field Protects biological systems Polarizer and all forms of life from all forms of radiation; Cancels out all x-ray effects from such items as food and water Magnetic Trifield Meter Current Interface with normal transport of ions across cell membranes Acupuncture Magneto-Therapeutic Improved circulation, device consisting of approximately heighten blood oxygen 10 discs used piece by piece in level, relieves pain, affected areas etc., from the effects of magnetic force in medical treatment Eye massagers, (battery operated) "Massage" the eyes as action have stimulated the self-disciplined Known Shipper: nerves of the eyes and helped them to resume Laxus Products Ltd. their normal function. 62 W 4th Ave #110 Thus the stress can be Vancouver, B.C., Canada V5Y 1G3 released; "help promote ID# XCLAXPRO11OVAN stronger blood circulation, prevent near sight or short sight; may reduce the speed of increase of short sight; may delay the coming of presbyopia; may prevent eye bags, eye-palpebral black eyes bags or little wrinkles around the eyes." Magnetized drinking cup The product which include, but are not limited to, the prevention and cure of urinary calculus, renal calculus, thrombus, arteriosclerosis, hypertension, oral sores and digestive system diseases. Ceramic Magnetic Cups The supplementary curative effect on the calculus in the gallbladder, the bile duct and the kidney; diabetes; hypertension; and coronary heart disease. Metal circular bowl entitled Any therapeutic claims the "SUPERCONDUCTOR" including but not limited to diabetes, leukemia, meningitis, multiple sclerosis, and tuberculosis. MFR/SHIPPER: Robert McFarland dba Radionics Institute 411-75 Eastdale Avenue Toronto, Ontario Canada Shanghai Electronics China, Peoples Ceramic Magnetic Componen (CN, 280) Cup 816 Yan An Road 5/16/94 Shanghai, PROC MID #CNSHAELE816SHA Auricular Candles Effective in treatment of ear wax with Otoska oil. build-up, hearing problems, sinus congestion, frequent migraines and ear aches. 4/3/96 MFR: (Candles) Europe Cosmetiques 3471 Bld. Thimens St. Laurent, Quebec H4R 1 V5 Canada MID# CAEURCOS3471SAI MFR: (Oil) Nature Beaute Sante 750 Montain Sights Montreal, Quebec Canada FEI# 1000481474 MID# XQNATBEA7500MON Automatic Electronic Treats diabetes mellitus, hyperlipemia (lipid Stimulator metabolism), atherosclerosis, relieves stress a.k.a: Autonomous and depression, chronic constipation, sexual Electronic Stimulator, disturbances, detoxification, ischemic heart AES, Life Saver disease, cardiac arrhythmia, paralysis, and (a small capsule for enhances immunity level swallowing, inserting in vagina, rectum, or through Product Code = DE incision in intestine) MFR: Aoot, Zavod Komponent, Factory Komponent, or Alta Company Ismailovskow sh71 Hotel Izmailovskow Delta Moscow, Russia FEI: 100058935 MID: RUFACKOM71MOS Alta Company (same address as above) FEI: 1000589836 MID: RUALTCOM71MOS Kencayd Consulting Ear Candles Promotes better hear- AKA Candela Earcandles (77[][][]) ing, better lymphatic 555 Ridley Drive 2/5/97 circulation, pressure Victoria, B.C., Canada regulation, etc. FEI# 3000189108 MID# XCKENCON555VIC Q-Tech Laboratories Bio-Electric Field Relief of arthritis Level 1\453 Ruthven St Enhancement Unit muscular aches & pains Toowoomba QLD (EEFE)/84--- allergies, incontinence Australia 8/30/00 Etc. FEI #3003088672 Superior Ear Candles Ear Candles Promotes better hear- Division of J&P; Holdings (77[][][]) ing, better lymphatic Box 137 2/5/97 circulation, pressure Parson, B.C., Canada regulation, etc. FEI# 3000189110 MID# XCSUPEAR137PAR Shenzhen Supernatural Hand Supernatural Hand Super Low Electronic Co. Ltd. Frequency Massager 903, 9/F, Bldg C. Model NM-166 Shenzhen Tainan Intlūl Bldg Renmen S. Road Product Code = 89ISA Shenzhen City, China 5/9/97 FEI #3000280636 Bruce Copen Enterprises Ltd. Radionic Instruments Diagnosis Lindfield Enterprise Park (including models MK7, of internal Lewes Road, West Sussex MK12, ASLD95, MARS III) disease England RH16 2LX & accessories FEI #3001746577 GPI - DE 9/3/02 AND Sussex College of Technology Waltham Forest Business Center 5 Blackhorse Lane London, E17 6DS, England FEI #3003766867 Globe Traders Inc Ethicon Prolene Mesh II Counterfeit- 15, Dr. VB Gandhi Marg 79FTL Packaging may 1st Floor, Fort 2/10/04 Show ethicon logo Mumbai, India printed in Copper FEI #3003249367 plate rather than Helvetica & pouch lacks single piece of adhesive backing Attachment Import Alert #80-06 Revised 5/16/94 Page 4 DEVICES EXCLUDED FROM THIS IMPORT ALERT The following devices are excluded from coverage under this Import Alert and any investigation of such devices should not be included. a. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine. b. Prescription devices, which are being marketed as such.