About This 510(k) Submission
K231166 is an FDA 510(k) clearance for the Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes, a Stimulator, Electrical, Non-implantable, For Incontinence (Class II — Special Controls, product code KPI), submitted by Zmi Electronics , Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on January 18, 2024, 268 days after receiving the submission on April 25, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5320.