Clearance Summary
RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV) received FDA 510(k) clearance under submission number K981506, sponsored by Repro-Med Systems, Inc.. 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 1998-06-25.
- Submission: K981506
- Applicant / Sponsor: Repro-Med Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5020
- Decision date: 1998-06-25
Classification & Regulation
This clearance is catalogued under FDA product code LKY and 21 CFR 876.5020, within the Gastroenterology, Urology review panel as a Class II device.