510(k) K260178

Pelvic Muscle Trainer (KM510, KM516B) by Shenzhen Konmed Technology Co., Ltd. — Product Code KPI

K260178 is an FDA 510(k) premarket notification submitted by Shenzhen Konmed Technology Co., Ltd. for the device "Pelvic Muscle Trainer (KM510, KM516B)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Shenzhen Konmed Technology Co., Ltd. has at least 6 other 510(k) clearances on record.