SGT · Electromagnetic Stimulator For Healthy Muscle Stimulation
Physical Medicine · 21 CFR 890.5850 · Class 2
Overview
| Product Code | SGT |
|---|---|
| Device Name | Electromagnetic Stimulator For Healthy Muscle Stimulation |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250896 | Aura Wave | Aura Wellness, LLC | Dec 2, 2025 | SESE |
Top Applicants
- Aura Wellness, LLC — 1 clearance
