510(k) K972054 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
INNOVA RECTAL REUSABLE ELECTRODE/COMFORTPULSE REGULAR OR SMALL REUSABLE ELECTRODE
| Applicant | Empi, St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 14, 1997 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972054
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.