Product code SGT

Device name

Electromagnetic Stimulator For Healthy Muscle Stimulation

Medical specialty

Physical Medicine

Device class

2

Regulation number

890.5850

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset