510(k) K252601 ยท KPI Stimulator, Electrical, Non-Implantable, For Incontinence
Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)
| Applicant | Hunan Accurate Bio-Medical Technology Co., Ltd., Changsha, CN |
| Decision | Substantially Equivalent, May 14, 2026 |
| Received | Aug 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252601
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.