Clearance Summary
HANDI-TRAK WHEELCHAIR SNOW CHAINS received FDA 510(k) clearance under submission number K904913, sponsored by Handi-Trak, 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 1990-11-07.
- Submission: K904913
- Applicant / Sponsor: Handi-Trak, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1990-11-07
Classification & Regulation
This clearance is catalogued under FDA product code KNN and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.