Pelvic Muscle Trainer (4 models)— 510(k) K252601
Substantially EquivalentHunan Accurate Bio-Medical Technology Co., Ltd.
FDA 510(k) clearance K252601 for Pelvic Muscle Trainer (4 models), Substantially Equivalent on 2026-05-14. Applicant: Hunan Accurate Bio-Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changsha, CN
Recent devices under product code KPI
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More clearances from Hunan Accurate Bio-Medical Technology Co., Ltd.
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