FDA product code NUW: Stimulator, Muscle, Powered, Dental
NUW is the FDA product code for stimulator, muscle, powered, dental. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Dental panel. FDA has cleared 9 510(k) submissions under NUW, 1 in the last five years, from 5 different applicants. The average 510(k) review took 128 days (median 155); 203 days on average over the last three years.
Definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Muscle, Powered, Dental |
| Device class | Class II |
| Regulation | 21 CFR 890.5850 |
| Review panel | DE — Dental |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NUW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 155 |
| 2025 | 1 | 203 |
Compare with all 510(k) review times · Search every NUW clearance
Top NUW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myo-Tronics Research, Inc. | 3 | 1984-11-19 |
| Myotronics-Noromed, Inc. | 2 | 2004-07-20 |
| Microcurrent Research, Inc. | 2 | 1990-10-09 |
| BTL Industries, Inc. | 1 | 2025-05-09 |
| Ito Co., Ltd. | 1 | 2021-05-05 |
Most recent NUW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243290 | BTL Industries, Inc. | BTL-785MJ | 2025-05-09 | 203 |
| K203525 | Ito Co., Ltd. | D function | 2021-05-05 | 155 |
| K040400 | Myotronics-Noromed, Inc. | MYO-TRODE SG DISPOSABLE ELECTRODE | 2004-07-20 | 154 |
| K031998 | Myotronics-Noromed, Inc. | MODEL J-5 MVO-MONITOR | 2003-07-24 | 27 |
| K901902 | Microcurrent Research, Inc. | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | 1990-10-09 | 165 |
Recalls for NUW devices
openFDA lists no recalls for product code NUW.
Frequently asked questions
What is FDA product code NUW?
NUW is the FDA product code for stimulator, muscle, powered, dental. It is a Class II device, regulated under 21 CFR 890.5850 and reviewed by the Dental panel.
What device class is NUW?
Class II, regulation 21 CFR 890.5850. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUW?
Across 9 cleared submissions the average was 128 days from receipt to decision (median 155).
Which companies have the most NUW clearances?
Myo-Tronics Research, Inc. (3); Myotronics-Noromed, Inc. (2); Microcurrent Research, Inc. (2); BTL Industries, Inc. (1); Ito Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NUW
- Run a recall and safety report across every NUW manufacturer
- Watch product code NUW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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