SGT

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Electromagnetic Stimulator For Healthy Muscle Stimulation

Device class

Class II (moderate risk)

Regulation

21 CFR 890.5850

Medical specialty

Physical Medicine

Flags

Third-party review eligible

FDA definition

A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.

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