510(k) K193364 ยท HIR Perineometer
Intimate Rose Kegel Exercise System
| Applicant | Plus EV Holdings Dba Intimate Rose, North Kansas City MO, US |
| Decision | Substantially Equivalent, Aug 24, 2020 |
| Received | Dec 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193364
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.