Clearance Summary
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 received FDA 510(k) clearance under submission number K993406, sponsored by Permobil AB. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2000-12-18.
- Submission: K993406
- Applicant / Sponsor: Permobil AB
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3860
- Decision date: 2000-12-18
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.