510(k) K162010 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
HPM-6000U
| Applicant | BTL Industries, Inc., Framingham MA, US |
| Decision | Substantially Equivalent, Dec 13, 2016 |
| Received | Jul 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162010
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.