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
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