Clearance Summary
PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR received FDA 510(k) clearance under submission number K884541, sponsored by Pro-Vertic, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1988-11-23.
- Submission: K884541
- Applicant / Sponsor: Pro-Vertic, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3900
- Decision date: 1988-11-23
Classification & Regulation
This clearance is catalogued under FDA product code IPL and 21 CFR 890.3900, within the Physical Medicine review panel as a Class II device.