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. 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. 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. Therefore, firms must comply with appropriate FDA premarket regulatory requirements before they can legally sell their stimulators.
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. Electrical muscle stimulators are considered devices under the Federal Food, Drug, and Cosmetic Act. Why does FDA regulate electrical muscle stimulators?Ī.
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