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IA #89-01 - Revised 3/19/97, "Electrical Muscle Stimulators and Iontophoresis Devices", Attachment I, 10/26/06, II, 7/18/06 *Note: This import alert is reissued to update the format, product code, and Center contact person. Changes and updates are identified with an asterisk (*).* TYPE OF ALERT: Intensified Coverage *(Note: This import alert contains guidance to FDA field personnel only. It does not establish any requirements, or create any rights or obligations on FDA or on regulated entities.)* PRODUCT: Electrical Muscle Stimulators and Iontophoresis Devices PRODUCT CODES: *89IPF (Muscle Stimulators) 89KTB (Iontophoresis)* PROBLEM: Labeling - These electrical devices are prescription devices and are misbranded when labeled for lay use. In addition, the muscle stimulators are misbranded when inappropriate claims, such as weight reduction, are made. PAC: 82007 COUNTRY: All MANUFACTURER/ SHIPPER: Various (see attachment) CHARGE: If appropriate, charge: Devices lacking prescription legend or otherwise not in compliance with 21 CFR 801.109: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a prescription device labeled for lay use, and thus lacks adequate directions for its use [Misbranded, 502(f)(1)]." Devices with inappropriate claims: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to lack adequate directions for its intended use [Misbranded, 502(f)(1)]." Devices with labeling claims that are false and misleading: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that its labeling appears to be false or misleading [Misbranded, 502(a)]." Devices marketed without premarket notification: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a premarket notification was not submitted pursuant to section 510(k) [Misbranded, 502(o)]." Charges may be combined as appropriate. Note: Depending on the actual electromechanical configuration of the device it may also be misbranded within the meaning of Section 502(f)(2). RECOMMENDING OFFICE: CDRH and SAN-DO REASON FOR ALERT: The use of these electrical devices in health clubs, beauty salons and figure salons has been increasing for several years. While there are legitimate uses for both muscle stimulators and iontophoresis devices, they are prescription devices and are misbranded when labeled for lay use. In addition, muscle stimulators are misbranded when any of the following claims are made: girth reduction, loss of inches, weight reduction, cellulite removal, bust development, body shaping and contouring, and spot reducing. A large number of these products are imported with the list increasing (see attachments I and II). The following information is provided to aid the districts in identifying and detaining misbranded muscle stimulators and iontophoresis devices. Muscle Stimulators: Electrical muscle stimulators are prescription devices used to repeatedly contract muscles by passing electrical currents through electrodes in contact with the body. One or more pairs of electrodes, along with creams or gels, may accompany the device, which may be powered by battery or line voltage. There are currently no acceptable uses for these devices when labeled for over-the-counter use. When labeled for Rx use by a licensed practitioner, the following uses are generally recognized as acceptable: 1. Relaxation of muscle spasm. 2. Prevention or retardation of disuse atrophy. 3. Muscle reeducation. 4. Increasing local blood circulation. 5. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. 6. Maintaining or increasing range of motion. The labeling must contain the prescription legend and comply with all the conditions of 21 CFR 801.109. Muscle stimulators are misbranded when any of the following claims are made: girth reduction, loss of inches, weight reduction, cellulite removal, bust development, body shaping and contouring, and spot reducing. Iontophoresis Devices An iontophoresis device is a prescription device used to introduce ions of soluble salts (i.e., medications) by use of direct current into the tissues of the body for therapeutic or diagnostic purposes. There are currently no acceptable uses for iontophoresis devices when they are labeled for over-the-counter use. When labeled for Rx use by a licensed practitioner, the only approved use is the diagnosis of cystic fibrosis explained in the final classification 21 CFR Part 890.5525, * or for use with a drug, if labeling includes adequate directions for use of the device with that drug.* All other uses would result in the device being considered Class III, requiring premarket approval. The labeling for this device must contain the prescription legend and comply with all the required information of 21 CFR 801.109. The names of these devices, the names of the companies and the labeling claims may change in the future. Some devices are being promoted for both muscle stimulation and iontophoresis. There is no objection to combined labeling or use as long as the labeling requirements for both uses are met and FDA has determined it to be substantially equivalent to preamendment electrical muscle stimulators and iontophoresis devices. GUIDANCE: *Consult the Center for Devices and Radiological Health (HFZ-343), Edgardo Santiago at (301) 594-4659* about appropriate charges, adequate warnings, and whether detention is warranted. *For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007.* FOI: No purging required. KEYWORDS: Electric Muscle Stim, Iontophoresis Device, Muscle Stimulators, Slendertone. REVISED BY: Alwin Collins, O & P SDWG, DIOP, (301) 443-6553. DATE LOADED INTO FIARS: MARCH 19, 1997 Import Alert #89-01 10/26/06 Attachment I KNOWN MANUFACTURERS OF ELECTRICAL MUSCLE STIMULATORS Manufacturer Importer Name of Device Anti-Aging International Unknown Electrical Muscle Inc. Stimulator 76 Hazelton Avenue 6/30/95 Toronto, Ontario Canada M5R 2E2 MID #XOCANTAGI76TOR Shipper: Name Unknown 122 Davenport Road Toronto, Ontario Canada MID# CAUNK122TOR Body Clock Health Care Ltd. Electronic Muscle Stimulator 108 George Lane 89I--PF South Woodford 10/26/06 London, UK FEI# 3003267895 Bretherton Therapy Products Lipodren 29 Orchard Road Muscle Stimulator Beeston, Sandy, 84NFO, 89IPF Bedfordshire SG19 1PJ 89NGX, 89LPQ United Kingdom 7/20/05 FEI# 3003057408 Compex S.A. Compex-Sport Electrical Muscle Chemin du Devent Stimulator/89IPF CH-1024 Ecublens 5/23/01 Switzerland FEI #3002806744 SHIPPER: Chau Sport 5 Rue President Favre Annecy, France FEI #3003232528 Daito Electric Machine Industry Co. Ltd Stimulator, Muscle, Powered 9-11, Showa-Cho (body building belt) Higashi-Osaka, Japan OSIM Pro-Therapist, FEI #1000254767 Model OS-205 73BXM, 77ETN, 84NFO, 89IPF, 89MPH, 89NGX 8/29/02 Deutsche Nemectron Nemectron Belmont Electrodyn CII, Germany New York, NY Dermaphoresis Dezac, Ltd. Manufacturer Electronic Muscle 54 Bath Road Stimulator Dr-Ho's Inc. Dr-Ho's Muscle Massage P.O. Box 26543 Muscle Therapy Systems Markville R.P.O. 89IPF Markham, Ontario, Canada L3R0M4 4/17/00 FEI# 3002923277 Dr. Ho's Muscle Therapy 48 Norwich Drive Markham, Ontario, Canada L3P 6R4 FEI# 3002267880 Dr. Ho's Inc. 176 Bullock Dr. #13 Markham, Ontario, Canada L3P 7N1 FEI# 3002923326 Cheltenham, Gloster 2/28/97 United Kingdom FEI #1000599629 MID #GBDEZLTD54CHE (Manufacturer) Stimulator, Muscle, Powered Unknown (body building belt) Ab-Sonic brand (Shipper) (Importer) "the smart electronic massage Comet (HK) Ltd. Fong Chan fitness belt" Unit 1118-1119, Metro dba Tung Hing USA 73BXM, 77ETN, 84NFO, 89IPF, Centre II Industries Co. 89MPH, 89NGX 21 Lam Hing St., Bay 501C Poplar Ave. 8/29/02 Kowloon, Hong Kong Millbrae, CA 94030 FEI #3003587846 FEI #3003570103 Edith Serei Co., Ltd. Edith Serei Co., Ltd. Electromass Canada New Jersey Formmagia S.R.L. AS 43 Suntronic Aesthetic 20089 Valleambrosia de Rozzano (MI) Treatment Via Varalli 1, Capannone A/1, Italy 89IPF FEI# 3005787843 84GXY 07/18/06 Formmagia S.R.L. Via Giuseppe Frua 22 Milan, Italy FEI# 3002928645 Generali Tecniche P-Ryton Corp. Dermaphoresis, Elettroestetiche, Italy Long Island City, NY Vibroelectronic Homesquare Int'l, Ltd. ABGYMNIC Electronic Gymnastic Device/ Rm. 3115,31/F Hong Kong 89--GZJ Plaza 89--NHH 188 Connaught Road West 89--IPF Hong Kong, 89--NFO FEI #3003538851 89--NGX 89--ISA 89--LYG 6/27/02 International Esthetics Global Esthetics Multitone Muscle- Corporation Seattle, WA toner North Vancouver, B.C. Multitone Trans- Canada dermal Facial Unit Shipper: Global Esthetics Vancouver, B.C., Canada Mayfair Medical Supplies The Scarf Co. Slim-up Kowloon, Hong Kong Acupunture Equipment Beauty Pulse & Tens Tucson, AZ 85705 Sa Mas S.r.l. N/A Attila Evoluzione Via Tarlazzi 5 Electrical Stimulation 31014 Colle Umberto device Umberto, Italy 84GZJ FEI# 3003238077 4/11/01 Shenyang Xinzhen Medical Electronic BFGF-8 Computer Controlled Instrument Company Weight Reducing Machine No. 52, North Huanghe St Muscle Stimulator Shengyang, 84NFO, 89IPF China 89NGX, 89LPQ FEI# 3004467572 7/20/05 Shenzhen Futian Light Industrial N/A Stimulator, Muscle, Powered & Textile Products Import & (body building belt) Export Co. 73BXM, 77ETN, 84NFO, 89IPF 6/F Futian Trade & Business Building 89MPH, 89NGX Fuhua Road 51 6/20/02 Shenzhen, China FEI #3003606121 Slendertone Ltd. Bloomex Int't. Slendertone England New York, NY Taiwan Creations Joe L. Co., Ltd. Home Slim Taipei, Taiwan Healthtronic, Muscle Stimulator and Slimming System 2/1/94 Alpha-wave Healthtronic, Muscle Stimulator and Slimming system 2/1/94 Ultra Scientific Instruments `Gloria Moore Inc. Ultratone EMS devices, Ltd.(aka Ultratone) 82 Sidney Court including - Kingnorth Technology Park San Rafael, CA Ultratone Facial Wotton Rd., Ashford, 94903 Kent TN23 6LN FEI# 300205934 Stimulator United Kingdom Ultratone Salon 10 Plus FEI# 1000313394 Ultratone Pro 20 Ultratone Super Pro 20 Ultratone Futura Plus 89L- - PQ 5/9/01 Zot Nederland B.V. Amsterdam N/A Stimulator, Muscle, Powered Lugano Branch Innuelle Brand Tex-El System Corsa Elvezia 14 73BXM, 77ETN, 84NFO, 89IPF CH-6900, Lugano, Switzerland 89MPH, 89NGX FEI# 3003426581 6/20/02 Import Alert #89-01 7/18/06 Attachment II KNOWN MANUFACTURERS OF IONTOPHORESIS DEVICES Manufacturers Importer Name of Device Generali Tecniche P-Ryton Corp. Lisa Derm, Elettroestetiche, Italy Long Island City, NY Thermoslim, Dermophoresis Vibroelectronic Deutsche Nemectron Nemectron Belmont Electrodyn CII, Germany CII New York, NY Doctors Technology Co. Ltd. Up5 Skin care system- iontophoresis 614-3 Shinsa-dong, Kangnam-ku device Seoul, Korea 89KTB FEI# 3004429497 3/26/04 Shipper: JMEC Co. Ltd. Oshima Bldg. 3-31-3 Yushima Bunkyo-ky, Tokyo, Japan FEI# 3004429507 Edith Serei Co., Ltd. Edith Serei Co., Ltd. Galvanique, Canada New Jersey Cathiolyse Formmagia S.R.L. AS 43 Suntronic Aesthetic 20089 Valleambrosia de Rozzano (MI) Treatment Via Varalli 1, Capannone A/1, Italy 89KTB FEI# 3005787843 84GXY 07/18/06 Formmagia S.R.L. Via Giuseppe Frua 22 Milan, Italy FEI# 3002928645 Ionto-Comed Ionto-Comed U.S. Inc. Ionto-Lift No. 8223 Gmbh, West Germany St. Paul, MN i2M Sarl 16 Bis N/A Idrostar, Fosses Saint Julien Iontophoresis BP200 14011 Device Caen Cedax, France 89EGJ, 89KTB FEI #3003614118
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