FDA product code SGT: Electromagnetic Stimulator For Healthy Muscle Stimulation
SGT is the FDA product code for electromagnetic stimulator for healthy muscle stimulation. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under SGT, 2 in the last five years. The average 510(k) review took 138 days (median 138); 138 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Electromagnetic Stimulator For Healthy Muscle Stimulation |
| Device class | Class II |
| Regulation | 21 CFR 890.5850 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for SGT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 252 |
| 2026 | 1 | 25 |
Compare with all 510(k) review times · Search every SGT clearance
Top SGT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aura Wellness, LLC | 2 | 2026-08-31 |
Most recent SGT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262788 | Aura Wellness, LLC | Nova HD+ | 2026-08-31 | 25 |
| K250896 | Aura Wellness, LLC | Aura Wave | 2025-12-02 | 252 |
Recalls for SGT devices
openFDA lists no recalls for product code SGT.
Frequently asked questions
What is FDA product code SGT?
SGT is the FDA product code for electromagnetic stimulator for healthy muscle stimulation. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Physical Medicine panel.
What device class is SGT?
Class II, regulation 21 CFR 890.5850. Typical premarket route: 510(k).
How long does a 510(k) take for product code SGT?
Across 2 cleared submissions the average was 138 days from receipt to decision (median 138).
Which companies have the most SGT clearances?
Aura Wellness, LLC (2).
Next steps
- Run an FDA pathway report with predicate devices for product code SGT
- Run a recall and safety report across every SGT manufacturer
- Watch product code SGT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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