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.
Summary
Hunan Accurate Bio-Medical Technology's Pelvic Muscle Trainer is listed in four models: PC22A, PC22A-L, PC22E and PC22E-L. The product code is KPI, non-implantable electrical stimulators for incontinence.
Class II, 21 CFR 876.5320. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
The company filed from Changsha, China. The decision came 269 calendar days after receipt (August 18, 2025 to May 14, 2026).
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
- Product 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
view all- K262353 — BTL-299-F
- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from Hunan Accurate Bio-Medical Technology Co., Ltd.
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