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