Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5850](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5850) → SGT — Electromagnetic Stimulator For Healthy Muscle Stimulation

# SGT · Electromagnetic Stimulator For Healthy Muscle Stimulation

_Physical Medicine · 21 CFR 890.5850 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/SGT

## Overview

- **Product Code:** SGT
- **Device Name:** Electromagnetic Stimulator For Healthy Muscle Stimulation
- **Regulation:** [21 CFR 890.5850](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5850)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **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](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/SGT/K250896.md) | Aura Wave | Aura Wellness, LLC | Dec 2, 2025 | SESE |

## Top Applicants

- Aura Wellness, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/SGT](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/SGT)

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