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) → NUW — Stimulator, Muscle, Powered, Dental

# NUW · Stimulator, Muscle, Powered, Dental

_Physical Medicine · 21 CFR 890.5850 · Class 2_

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

## Overview

- **Product Code:** NUW
- **Device Name:** Stimulator, Muscle, Powered, Dental
- **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 (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243290](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K243290.md) | BTL-785MJ | BTL Industries, Inc. | May 9, 2025 | SESE |
| [K203525](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K203525.md) | D function | Ito Co., Ltd. | May 5, 2021 | SESE |
| [K040400](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K040400.md) | MYO-TRODE SG DISPOSABLE ELECTRODE | Myotronics-Noromed, Inc. | Jul 20, 2004 | SESE |
| [K031998](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K031998.md) | MODEL J-5 MVO-MONITOR | Myotronics-Noromed, Inc. | Jul 24, 2003 | SESE |
| [K901902](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K901902.md) | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Microcurrent Research, Inc. | Oct 9, 1990 | SESE |
| [K890143](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K890143.md) | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | Microcurrent Research, Inc. | May 1, 1989 | SESE |
| [K842224](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K842224.md) | BNS 40 | Myo-Tronics Research, Inc. | Nov 19, 1984 | SESE |
| [K842223](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K842223.md) | J4 MYO-MONITOR | Myo-Tronics Research, Inc. | Nov 19, 1984 | SESE |
| [K770252](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/NUW/K770252.md) | MONITOR, MYO, MODEL J3 | Myo-Tronics Research, Inc. | Feb 18, 1977 | SESE |

## Top Applicants

- Myo-Tronics Research, Inc. — 3 clearances
- Microcurrent Research, Inc. — 2 clearances
- Myotronics-Noromed, Inc. — 2 clearances
- BTL Industries, Inc. — 1 clearance
- Ito Co., Ltd. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com