SGT — Electromagnetic Stimulator For Healthy Muscle Stimulation Class II
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250896 | aura wellness | Aura Wave | December 2, 2025 |