Electromagnetic Stimulator For Healthy Muscle Stimulation
SGT is the FDA product code for Electromagnetic Stimulator For Healthy Muscle Stimulation, a class II device type, regulated under 21 CFR 890.5850. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SGT
- Device name
- Electromagnetic Stimulator For Healthy Muscle Stimulation
- FDA 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.
- Regulation
- 21 CFR 890.5850
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code SGT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code SGT| Applicant | Clearances |
|---|---|
| Aura Wellness, LLC | 1 |
| Aura Wellness, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.