K233364 is an FDA 510(k) clearance for the Axon Therapy. This device is classified as a Electromagnetic Stimulator, Pain Relief (Class II - Special Controls, product code QPL).
Submitted by Neuralace Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on January 10, 2024, 100 days after receiving the submission on October 2, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890. Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain..
| 510(k) Number | K233364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2023 |
| Decision Date | January 10, 2024 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | QPL - Electromagnetic Stimulator, Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain. |