510(k) K231166 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
| Applicant | Zmi Electronics , Ltd., Kaohsiung, TW |
| Decision | Substantially Equivalent, Jan 18, 2024 |
| Received | Apr 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231166
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.