NUW · Stimulator, Muscle, Powered, Dental
Physical Medicine · 21 CFR 890.5850 · Class 2
Overview
| Product Code | NUW |
|---|---|
| Device Name | Stimulator, Muscle, Powered, Dental |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243290 | BTL-785MJ | BTL Industries, Inc. | May 9, 2025 | SESE |
| K203525 | D function | Ito Co., Ltd. | May 5, 2021 | SESE |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | Myotronics-Noromed, Inc. | Jul 20, 2004 | SESE |
| K031998 | MODEL J-5 MVO-MONITOR | Myotronics-Noromed, Inc. | Jul 24, 2003 | SESE |
| K901902 | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Microcurrent Research, Inc. | Oct 9, 1990 | SESE |
| K890143 | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | Microcurrent Research, Inc. | May 1, 1989 | SESE |
| K842224 | BNS 40 | Myo-Tronics Research, Inc. | Nov 19, 1984 | SESE |
| K842223 | J4 MYO-MONITOR | Myo-Tronics Research, Inc. | Nov 19, 1984 | SESE |
| K770252 | 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
