510(k) K252334

PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) by Pontemedag — Product Code KPI

K252334 is an FDA 510(k) premarket notification submitted by Pontemedag for the device "PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)". The FDA issued a decision of Substantially Equivalent on April 17, 2026. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320.