510(k) K240805 ยท HIR Perineometer
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
| Applicant | Pelvital USA, Inc., Eagan MN, US |
| Decision | Substantially Equivalent, Aug 1, 2024 |
| Received | Mar 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240805
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.