K252601
- 510(k) number
- K252601
- Device name
- 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. CN
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2026-05-14
- Date received
- 2025-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252601.pdf
Official FDA record: K252601
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.