NUW
9 FDA 510(k) clearances · Product code
155 daysmedian time to decision
203 days90th percentile
9clearances measured
FDA profile
- Official device name
- Stimulator, Muscle, Powered, Dental
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- FDA definition
- Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BTL-785MJ (K243290) | BTL Industries, Inc. | 2025-05-09 |
| D function (K203525) | Ito Co., Ltd. | 2021-05-05 |
| MYO-TRODE SG DISPOSABLE ELECTRODE (K040400) | Myotronics-Noromed, Inc. | 2004-07-20 |
| MODEL J-5 MVO-MONITOR (K031998) | Myotronics-Noromed, Inc. | 2003-07-24 |
| ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE (K901902) | Microcurrent Research, Inc. | 1990-10-09 |
| ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON (K890143) | Microcurrent Research, Inc. | 1989-05-01 |
| BNS 40 (K842224) | Myo-Tronics Research, Inc. | 1984-11-19 |
| J4 MYO-MONITOR (K842223) | Myo-Tronics Research, Inc. | 1984-11-19 |
| MONITOR, MYO, MODEL J3 (K770252) | Myo-Tronics Research, Inc. | 1977-02-18 |
Track NUW automatically
Every clearance here is in the API, with alerts when new ones post.