Clearance Summary
ALL TERRAIN WHEELCHAIR (ATW) received FDA 510(k) clearance under submission number K003048, sponsored by Roll-Ability (Pty) , Ltd.. 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 2000-12-15.
- Submission: K003048
- Applicant / Sponsor: Roll-Ability (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2000-12-15
Classification & Regulation
This clearance is catalogued under FDA product code IOR and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.