510(k) K241862

Levina Pelvic Floor Muscle Stimulator (RS-48) by Zmi Electronics , Ltd. — Product Code KPI

K241862 is an FDA 510(k) premarket notification submitted by Zmi Electronics , Ltd. for the device "Levina Pelvic Floor Muscle Stimulator (RS-48)". The FDA issued a decision of Substantially Equivalent on March 27, 2025. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Zmi Electronics , Ltd. has at least 2 other 510(k) clearances on record.