510(k) K241862 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Levina Pelvic Floor Muscle Stimulator (RS-48)
| Applicant | Zmi Electronics , Ltd., Kaohsiung, TW |
| Decision | Substantially Equivalent, Mar 27, 2025 |
| Received | Jun 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241862
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.