510(k) K222528 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
| Applicant | Well-Life Healthcare Limited, New Taipei City, TW |
| Decision | Substantially Equivalent, Dec 29, 2022 |
| Received | Aug 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222528
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.