K233485 is an FDA 510(k) clearance for the M-Wave. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Zynex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on January 26, 2024, 91 days after receiving the submission on October 27, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K233485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2023 |
| Decision Date | January 26, 2024 |
| Days to Decision | 91 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |