Clearance Summary
Levina Pelvic Floor Muscle Stimulator (RS-48) received FDA 510(k) clearance under submission number K241862, sponsored by Zmi Electronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-03-27.
- Submission: K241862
- Applicant / Sponsor: Zmi Electronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2025-03-27
Classification & Regulation
This clearance is catalogued under FDA product code KPI and 21 CFR 876.5320, within the Gastroenterology, Urology review panel as a Class II device.