Stimulator, Muscle, Powered, Dental
FDA product code NUW · Class II (moderate risk) · 21 CFR 890.5850 · Physical Medicine
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
9510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243290 | BTL-785MJNUW · Traditional | BTL Industries, Inc. | 05/09/2025SE |
| K203525 | D functionNUW · Traditional | Ito Co., Ltd. | 05/05/2021SE |
| K040400 | Myo-Trode SG Disposable ElectrodeNUW · Traditional | Myotronics-Noromed, Inc. | 07/20/2004SE |
| K031998 | Model J-5 Mvo-MonitorNUW · Special | Myotronics-Noromed, Inc. | 07/24/2003SE |
| K901902 | Acusource 600 for Use with TMJ ElectrodeNUW · Traditional | Microcurrent Research, Inc. | 10/09/1990SE |
| K890143 | Acutron Multiwave for Use in TMJ Syndrome Pain ConNUW · Traditional | Microcurrent Research, Inc. | 05/01/1989SE |
| K842224 | BNS 40NUW · Traditional | Myo-Tronics Research, Inc. | 11/19/1984SE |
| K842223 | J4 Myo-MonitorNUW · Traditional | Myo-Tronics Research, Inc. | 11/19/1984SE |
| K770252 | Monitor, Myo, Model J3NUW · Traditional | Myo-Tronics Research, Inc. | 02/18/1977SE |