510(k) K163288

Pelvifine Pelvic Muscle Trainer by Shenzhen Konmed Technology Co., Ltd. — Product Code KPI

K163288 is an FDA 510(k) premarket notification submitted by Shenzhen Konmed Technology Co., Ltd. for the device "Pelvifine Pelvic Muscle Trainer". The FDA issued a decision of Substantially Equivalent on January 18, 2018. 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.