IA #73-03 - 11/1/88, "Automatic Detention of Energy Point Stimulators" ATTACH 2/14/96 TYPE OF ALERT: Automatic Detention PRODUCT : Energy Point Stimulators (Medical Devices) PRODUCT CODE : 89[][][][][] PROBLEM : No Premarket approval application has been submitted COUNTRY : Known Countries: England (925) and Netherlands Antilles including Curacao (640) MANUFACTURER/ SHIPPER : Various (See attachment) CHARGE : "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated under Section 501 (f)(1)(B) in that an application for premarket approval has not been submitted." RECOMMENDING OFFICE : Center for Devices & Radiological Health, Office of Compliance (HFZ-300). REASON FOR ALERT : To prevent continuing importation of a medical device that does not have premarket approval. Since 1985 the agency has been aware of the use and distribution of these devices. Books and literature distributed with them claim that they are useful for non-invasive acupuncture. The devices are intended for trigger-point location of low-impedence or "energy points" (acupuncture points) on the skin. INSTRUCTIONS : Automatically detain all Energy Point Stimulators. Firms listed in the attachment to this alert have previously shipped these devices to importers/distributors in the United States. FOI : No purging required. Attachment - Import Alert #73-03 Revised 2/14/96 LIST OF FIRMS ASSOCIATED WITH THE MANUFACTURE AND DISTRIBUTION OF ENERGY POINT STIMULATORS ACUHEALTH (USA) PTY. LTD. 20750 Ventura Boulevard, Suite 300 Woodland Hills, CA 91364 (ACUHEALTH Professional 900 Energy Point Stimulator) Acumed Medical Supplies, Ltd. T.E.N.S. Pro 900 102-1 Director Ct. Energy Point Woodbridge, Ontario L4L 485 Stimulator Canada Product Code: 73BWK MID# CNACUMED1021WOO Class III 2/14/96 Auto-Compute Trading Ltd. Southall, Middlesex, England Customer Service (Northern Response) "Stimulator" 18 Skagway Avenue (Electro-Acupuncture Toronto, Ontario Stimulator) Canada M1M 3V1 Product Code: 73BWK MID#: CNNORRES18TOR Class III 9/19/95 Electronic Instrument Factory Beijing Haidian District Donghua (Product - Multiple Electronic Acupunctoscope) Haven-By-The-Sea 240 Davis Road Gabriola Island, B.C., Canada MID #XCHAVBY250GAB Search N Stim Electronic Acupuncture 11/21/94 Metradco MV, Curacao, Netherlands Antilles Remar (Grand Turk) Ltd. Southall, Middlesex, England Manufactured by: Xiapu Electronic Instrument Plant 1/27/92 Fujian, China (Product - Multifunctional Massager) Registered by: Wei Hua Chemical Products 10 Bell Court San Francisco, CA 94124 LIST OF FIRMS ASSOCIATED WITH THE MANUFACTURE AND DISTRIBUTION OF ENERGY POINT STIMULATORS Attachment - Import Alert #73-03 Revised 2/14/96 Page 2 Manufacturer: Nippon Athletic Industry Co., Ltd 8/4/92 Inoue Akasaka Bldg 3F, No. 6-8, 1-Chome, Akasaka, Minato-Ku, Tokyo, Japan Shipper: Japan Nac Co. Ltd Tokyo, Japan Product: Tsubo Points - Needleless acupuncture pen Manufacturer: Unknown 2/3/93 Shipper: R and R International (AKA International Health Organization) 2306 Sherbrooke East, Suite 1 Montreal, Quebec, Canada ID# XQRRINT2306MON ID# XQINTHEA2306MON Product: 1. Jupiter Electronic Acupuncture 2. Doctron Electro-Thermo Acupuncture Electro Medica Office Sonafon sonic acupuncture device Office: 32 Goodmark Pl., Unit 20 10/5/93 Rexdale, Ontario Canada M9W 6J4 Mailing: Box 3006, Stn. 'B' Rexdale, Ontario Canada M9V 2G2 MID# XOENEMED3006REX Taiwan Creations Joe L. Co., Ltd. Alpha-wave Healthtronic, Muscle Taipei, Taiwan Stimulator and Slimming Device 2/1/94 Manufacturer: Unknown HealthPoint Electro- stimulation unit Distributor: David Clapham Bollin House, Mobberley Cheshire WA 16 7LX United Kingdom ID# UKDAVCLACHE or LIST OF FIRMS ASSOCIATED WITH THE MANUFACTURE AND DISTRIBUTION OF ENERGY POINT STIMULATORS Attachment - Import Alert #73-03 Revised 2/14/96 Page 3 Distributor: David Clapham Dove Marketing Ltd., West Road Weaverham, Cheshire CW8 3HQ United Kingdom ID# UKDAVCLACHE