510(k) K233362 ยท HIR Perineometer
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
| Applicant | Pelvital USA, Inc., Eagan MN, US |
| Decision | Substantially Equivalent, Dec 29, 2023 |
| Received | Oct 2, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233362
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.