510(k) K191312 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Perfect PFE
| Applicant | Tenscare, Ltd., Epsom, GB |
| Decision | Substantially Equivalent, Nov 1, 2019 |
| Received | May 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191312
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.