Electrical Muscle Stimulation - FDA Certification in USA

FDA Certification in USA

The U.S. Food and Drug Administration (FDA) certifies and releases EMS devices into two broad categories: over-the counter devices (OTC), and prescription devices. OTC devices are marketable only for muscle toning; prescription devices can only be purchased with a medical prescription for therapy and should be used under supervision of an authorized practitioner, for the following uses:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy;
• Increasing local blood circulation;
• Muscle re-education;
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
• Maintaining or increasing range of motion.

The FDA mandates that manuals prominently display contraindication, warnings, precautions and adverse reactions, including: no use for wearer of pacemaker; no use on vital parts, such as carotid sinus nerves, across the chest, or across the brain; caution in the use during pregnancy, menstruation, and other particular conditions that may be affected by muscle contractions; potential adverse effects include skin irritations and burns

Only FDA-certified devices can be lawfully sold in the US without medical prescription. These can be found at the corresponding FDA webpage for certified devices. The FTC has cracked down on consumer EMS devices that made unsubstantiated claims; many have been removed from the market, some have obtained FDA certification.