Submission Details
| 510(k) Number | K222729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2022 |
| Decision Date | March 28, 2023 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |