Electromagnetic Stimulator For Healthy Muscle Stimulation
FDA product code SGT · 2 cleared devices
- Regulation
- 21 CFR 890.5850
- Review panel
- PM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2025-12-02 – 2026-08-31
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.
Aura Wave
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