Clearance Summary
KEGEL8 PELVIC EXERCISER, MODEL OPH 400 received FDA 510(k) clearance under submission number K081480, sponsored by Ne Services , 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 2008-09-12.
- Submission: K081480
- Applicant / Sponsor: Ne Services , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5320
- Decision date: 2008-09-12
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.