Clearance Summary
COMMUTER (MANUAL/POWER WHEELCLHAIR) received FDA 510(k) clearance under submission number K934232, sponsored by Fortress Lite-Style Wheelchairs, 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 1994-03-29.
- Submission: K934232
- Applicant / Sponsor: Fortress Lite-Style Wheelchairs, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 1994-03-29
Classification & Regulation
This clearance is catalogued under FDA product code ITI and 21 CFR 890.3860, within the Physical Medicine review panel as a Class II device.