Electronic Muscle Stimulators
Consumer Information on Electronic Muscle Stimulators
Q. Why does FDA regulate electrical muscle stimulators?
A. Electrical muscle stimulators are considered devices under the Federal
Food, Drug, and Cosmetic Act. Under this law and the agency's regulations,
the FDA is responsible for regulating the sale of all electrical muscle
stimulators in the United States. Therefore, firms must comply with appropriate
FDA premarket regulatory requirements before they can legally sell their
stimulators. Most electrical muscle stimulators (EMS devices) that have
been reviewed by FDA are intended for use in physical therapy and rehabilitation
under the direction of a health care professional. If a company wants
to sell EMS devices directly to consumers, the company needs to show FDA
it can be used safely and effectively in that setting.
Q. These electrical muscle stimulators are advertised not only to
tone, firm, and strengthen abdominal muscles, but also to provide weight
loss, girth reduction, and "rock hard" abs. Do they really work?
A. While an EMS device may be able to temporarily strengthen, tone or
firm a muscle, no EMS devices have been cleared at this time for weight
loss, girth reduction, or for obtaining "rock hard" abs.
Q. Is FDA concerned about the unregulated marketing of these devices?
A. Yes. FDA has received reports of shocks, burns, bruising, skin irritation,
and pain associated with the use of some of these devices. There have
been a few recent reports of interference with implanted devices such
as pacemakers and defibrillators. Some injuries required hospital treatment.
It is very important that these devices be properly designed, manufactured,
and labeled with clear and complete instructions for use and that anyone
using them follows the instructions carefully. FDA is also concerned because
many of these devices have cables and leads. If those cables and leads
do not comply with electrical safety standards, there is the possibility
of electrocution by users and other household members. FDA is currently
investigating firms that are illegally marketing EMS devices.
Q. What does FDA regulation accomplish?
A. Firms that market EMS devices are required to comply with appropriate
FDA premarket regulatory requirements before they may legally sell their
devices. The firm must be able to demonstrate that these devices are as
safe and as effective as similar devices that are legally marketed. Devices
may only be marketed for uses that are established for the device or for
uses that the firm can support with data. At this time, FDA is not aware
of scientific information to support many of the promotional claims being
made for numerous devices being widely promoted on television, infomercials,
newspapers, and magazines.
Q. Why should I select an electrical muscle stimulator that is legally
marketed according to FDA regulations?
A. Electrical Muscle Stimulators that have not met FDA premarket requirements
are illegal, and the FDA has not determined whether or not they are properly
designed, manufactured, and labeled to provide reasonable assurance that
they are safe and effective.
Q. Does that mean that it's unsafe to use an electrical muscle stimulator
that has not met FDA requirements?
A. Using a product that has not met FDA requirements isn't necessarily
unsafe or dangerous. But it could be. FDA has received reports of shocks,
burns, bruising, skin irritation, pain, and interference with other critically
important medical devices (e.g., pacemakers) associated with the use of
unregulated products. Unregulated devices also may have safety problems
associated with cables and leads that can lead to accidental shock and
electrocution by users and other household members, including children.
Q. If I use an electrical muscle stimulator that has met FDA regulatory
requirements, will it give me the same kind of effect that lots of sit-ups,
stomach crunches and other abdominal exercises will?
A. Using these devices alone will not give you "six-pack" abs.
Applying electrical current to muscles may cause muscles to contract.
Stimulating muscles repeatedly with electricity may eventually result
in muscles that are strengthened and toned to some extent but will not,
based on currently available data, create a major change in your appearance
without the addition of diet and regular exercise.
Q. But hasn't FDA cleared electrical muscle stimulators to treat medical
A. Yes. The FDA has cleared many electrical muscle stimulators for prescription
use in treating medical conditions. Doctors may use electrical muscle
stimulators for patients who require muscle re-education, relaxation of
muscle spasms, increased range of motion, prevention of muscle atrophy,
and for treating other medical conditions which usually result from a
stroke, a serious injury, or major surgery. Again, the effect of using
these devices is primarily to help a patient recover from impaired muscle
function due to a medical condition, not to increase muscle size enough
to affect appearance.
Q. Are there any OTC EMS devices that have met FDA's regulatory requirements?
A. Yes. At this time, Slendertone Flex marketed by BMR NeuroTech, Inc.,
has been cleared by FDA for toning, strengthening and firming abdominal
Q. How do I report a problem with an EMS device?
A. Medical device malfunctions can be reported directly to the manufacturer.
You can also report to MedWatch, the FDA's voluntary reporting program.
You may submit reports to MedWatch one of four ways: online at http://www.accessdata.fda.gov/scripts/medwatch/
by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to
MedWatch, Food and Drug Administration, HF-2, 5600 Fishers Lane, Rockville,