510(k) K053434 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
MYOTRAC INFINITI ELECTRICAL STIMULATOR
| Applicant | Thought Technology , Ltd., Montreal, Quebec, CA |
| Decision | Substantially Equivalent, Mar 15, 2006 |
| Received | Dec 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053434
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.