NUW — Stimulator, Muscle, Powered, Dental Class II
FDA product code NUW covers "Stimulator, Muscle, Powered, Dental", a Class II medical device regulated under 21 CFR 890.5850. Submissions are reviewed by the Physical Medicine panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NUW
- Device Class
- Class II
- Regulation Number
- 890.5850
- Submission Type
- 510(k)
- Review Panel
- DE
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243290 | Btl Industries | BTL-785MJ | May 9, 2025 |
| K203525 | Ito Co | D function | May 5, 2021 |
| K040400 | Myotronics-Noromed | MYO-TRODE SG DISPOSABLE ELECTRODE | Jul 20, 2004 |
| K031998 | Myotronics-Noromed | MODEL J-5 MVO-MONITOR | Jul 24, 2003 |
| K901902 | Microcurrent Research | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Oct 9, 1990 |
| K890143 | Microcurrent Research | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | May 1, 1989 |
| K842224 | Myo-Tronics Research | BNS 40 | Nov 19, 1984 |
| K842223 | Myo-Tronics Research | J4 MYO-MONITOR | Nov 19, 1984 |
| K770252 | Myo-Tronics Research | MONITOR, MYO, MODEL J3 | Feb 18, 1977 |