510(k) K252831

Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) by Dolanvy (Suzhou) Medical Technology Co., Ltd. — Product Code KPI

K252831 is an FDA 510(k) premarket notification submitted by Dolanvy (Suzhou) Medical Technology Co., Ltd. for the device "Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)". The FDA issued a decision of Substantially Equivalent on April 28, 2026. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320.