Muscle Stimulators, Do They Work? (cont.)

Question: Are there any Over-The-Counter EMS devices that have met FDA's regulatory requirements?

Answer:
Yes. At this time, Slendertone Flex marketed by BMR NeuroTech, Inc., has been cleared by FDA for toning, strengthening and firming abdominal muscles.

Question: How do I report a problem with an EMS device?

Answer:
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.accessdatAnswer:fdAnswer: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, MD 20857

For additional information, please visit the following areas:


Portions of the above information was provided with the kind permission of the Food and Drug Administration
(http://www.fda.gov)


Last Editorial Review: 5/9/2002


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