NUW
- Product code
- NUW
- Device name
- Stimulator, Muscle, Powered, Dental
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5850
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 9
FDA classification definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243290 | 2025-05-09 | BTL Industries, Inc. | BTL-785MJ |
Official FDA classification page: NUW
Classification and pathway per current FDA publications. Data from openFDA (CC0).