510(k) K252601

Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) by Hunan Accurate Bio-Medical Technology Co., Ltd. — Product Code KPI

K252601 is an FDA 510(k) premarket notification submitted by Hunan Accurate Bio-Medical Technology Co., Ltd. for the device "Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)". The FDA issued a decision of Substantially Equivalent on May 14, 2026. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Hunan Accurate Bio-Medical Technology Co., Ltd. has at least 5 other 510(k) clearances on record.