K241228 is an FDA 510(k) clearance for the TENSWave. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Zynex Medical Officer (Englewood, US). The FDA issued a Cleared decision on August 27, 2024, 117 days after receiving the submission on May 2, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K241228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2024 |
| Decision Date | August 27, 2024 |
| Days to Decision | 117 days |
| Submission Type | Abbreviated |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |