Clearance Summary
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR received FDA 510(k) clearance under submission number K001298, 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 2000-07-18.
- Submission: K001298
- 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: 2000-07-18
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.