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.