STIMULATOR TENS SKIN

Firms that market EMS devices are required to comply with appropriate FDA premarket regulatory requirements before they may legally sell their devices. FDA is currently investigating firms that are illegally marketing EMS devices.Ī. 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 also concerned because many of these devices have cables and leads. 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. Some injuries required hospital treatment.

There have been a few recent reports of interference with implanted devices such as pacemakers and defibrillators.

STIMULATOR TENS SKIN

FDA has received reports of shocks, burns, bruising, skin irritation, and pain associated with the use of some of these devices. Is FDA concerned about the unregulated marketing of these devices?Ī. 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. 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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