FDA TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T97-41                         Sharon Snider:     301-827-6242
August 28, 1997                
                               Consumer Hotline:  800-532-4440


               CONSUMER ALERT ON THE STIMULATOR
     The Food and Drug Administration has been receiving
inquiries and consumer complaints about a device called the
Stimulator which has been widely promoted for relieving pain and
treating a variety of other medical problems.  This product has
not been approved by the FDA.
     The Stimulator is essentially an electric gas barbecue grill
igniter outfitted with finger grips.  A second product, the
Xtender, connects to the Stimulator so it can be used on hard-
to-reach parts of the body.  When pressed against the skin, the
Stimulator sparks and causes a small electric shock.  Makers of
the device claim it can relieve headaches, back pain, arthritis,
stress, menstrual cramps, earaches, sinus, nosebleeds, flu and
other ailments.  
     Because of its medical claims, the Stimulator is considered
a medical device.  The manufacturers, however, have not complied
with any FDA regulations that govern the marketing of medical
devices.  The companies have submitted no information to FDA
showing that the device is either safe or effective, or 
substantially equivalent to any other legally marketed medical
device.  Furthermore, the Better Business Bureaus in Ohio and
Florida have issued warnings to alert consumers that this product
is unlikely to work as advertised.
     In December, 1995, at FDA's request, the U.S. Justice
Department filed a request for preliminary injunction against
Universal Management Services, Inc. and Natural Choice, Inc.,
both of Akron, Ohio, to stop advertising, sale and distribution
of this product.  In January 1997, the District Court granted the
government's request.  In addition, over the past three years FDA
has sent warning letters to six companies about the marketing of 
this device.
     Recently, makers of the Stimulator mailed a letter to as
many as 1,200 customers who had ordered but not received the
device.  The letter falsely told customers that FDA confiscated
and cashed the checks they mailed for their unfilled orders for
the Stimulator.  The agency has brought this matter to the
attention of the U.S. District Court for the Northern District of
Ohio Eastern Division which is handling the injunction.
     The six firms that received warning letters--and their
products--are:  Natural Innovations, Inc., Canton, Ohio (The
Stimulator); Gandee Chiropractic Life Center, Akron (The
Stimulator); Self-Care, Emeryville, Calif. (The Stimulator); 
Magna Plus Inc., Twinsburg, Ohio (Acupoint Pulse Stimulator);
Bright Marketing, Burlington, Iowa (Piezo-DX Quartz Crystal
Stimulator); and Crystaldyne, Inc., Scottsdale, Ariz. (Crystal
Stimulator).              ####




This article comes from Science Blog. Copyright 2004
http://www.scienceblog.com/community




This article comes from Science Blog. Copyright 2004
http://www.scienceblog.com/community