510(k) K081480 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
KEGEL8 PELVIC EXERCISER, MODEL OPH 400
| Applicant | Ne Services , Ltd., Oxford OH, US |
| Decision | Substantially Equivalent, Sep 12, 2008 |
| Received | May 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081480
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.