510(k) K001515 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
| Applicant | The Prometheus Group, Duxbury MA, US |
| Decision | Substantially Equivalent, Jul 31, 2000 |
| Received | May 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001515
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.