510(k) K231166

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes by Zmi Electronics , Ltd. — Product Code KPI

K231166 is an FDA 510(k) premarket notification submitted by Zmi Electronics , Ltd. for the device "Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes". The FDA issued a decision of Substantially Equivalent on January 18, 2024. 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.