SGT — Electromagnetic Stimulator For Healthy Muscle Stimulation Class II
FDA product code SGT covers "Electromagnetic Stimulator For Healthy Muscle Stimulation", a Class II medical device regulated under 21 CFR 890.5850. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SGT
- Device Class
- Class II
- Regulation Number
- 890.5850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.