K203525 is an FDA 510(k) clearance for the D function. This device is classified as a Stimulator, Muscle, Powered, Dental (Class II - Special Controls, product code NUW).
Submitted by Ito Co., Ltd. (Kawaguchi-Shi, JP). The FDA issued a Cleared decision on May 5, 2021, 155 days after receiving the submission on December 1, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 890.5850. Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow..
| 510(k) Number | K203525 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2020 |
| Decision Date | May 05, 2021 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NUW - Stimulator, Muscle, Powered, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |
| Definition | Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow. |