SGT
- Product code
- SGT
- Device name
- Electromagnetic Stimulator For Healthy Muscle Stimulation
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5850
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250896 | 2025-12-02 | Aura Wellness, LLC | Aura Wave |
Official FDA classification page: SGT
Classification and pathway per current FDA publications. Data from openFDA (CC0).