Update Dec 4, 00SCHEME TO SELL GAS GRILL IGNITERS FOR PAIN RELIEF
BACKFIRES;
COURT ORDERS REFUND TO PURCHASES
In the November 30, 2000 FDA Talk Paper it was announced
that the US District Court judge ordered the maker and distributor of gas
grill igniters marketed for pain relief to begin refunding approximately
$82.00 to each purchaser of the fraudulent medical device. The device was
called the "The Simulator."
The device was manufactured and sold through Universal
Management Services, owned by the Moneas, and through Natural Choice, a
distributor managed by Universal Management. Some 800,000 of the devices
were sold between 1994 and 1997. The Stimulator was manufactured by
outfitting gas grill igniters with finger grips. Users were instructed to
apply the tip of the Stimulator to so-called acupressure points on the
body and press the plunger to send an electric current in to the body. The
companies also sold an accessory cord call the Xtender to help consumer’s
hard-to-reach areas of the body, such as the spine.
Ads claimed that the Stimulator could relieve many kinds
of pain, including migraine headaches, painfully swollen joints,
allergies, sciatica and carpal tunnel syndrome. Starting in 1994,
promotions for the product appeared in USA Today, The New Yorker, and
other magazines and newspapers, as well as in national TV infomercials
featuring celebrities such as daredevil Evel Knievel, basketball star Bill
Walton, and actress Lee Merriweather.
For more information on this Court action on an FDA issue
please go to the FDA’s website at
www.fda.gov/bbs/topics/ANSWERS/ANS01059.html
or contact mdi’s office for a copy of the announcement.
This is interesting to see how long the FDA took to take
this action. I had seen these infomercials and advertisements several
years ago and knew that this device was illegally being sold. This type of
marketing is being conducted to day on many other medical devices that are
being illegally sold. These devices are neither FDA approved or not
approved for over-the-counter use. If you plan to market your device and
are not sure of the legality as to whether it requires FDA clearance you
better make sure before you move a head. It could take the FDA several
years to take action but that should not give you a false sense of
security.
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