K210021 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 June 11, 2021, 158 days after receiving the submission on January 4, 2021.
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 | K210021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2021 |
| Decision Date | June 11, 2021 |
| Days to Decision | 158 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. |