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 effe
