The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone, firm, and temporarily strengthen muscles through using the electric current pulse generator and the noninvasive electrodes. The EMS belt is a battery powered muscle stimulator, an over-the-counter device indicated for using to stimulate healthy muscles to facilitate and improve muscle performance in the intended areas on the body, a complimentary way to perform muscular training.
An electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not a portable wearable device such as a wristband. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.