510(k) K241899

Pelvic Floor Stimulator (Intrelief PFE) by Easymed Instruments Co., Ltd. — Product Code KPI

K241899 is an FDA 510(k) premarket notification submitted by Easymed Instruments Co., Ltd. for the device "Pelvic Floor Stimulator (Intrelief PFE)". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Easymed Instruments Co., Ltd. has at least 2 other 510(k) clearances on record.