Clearance Summary
WHEELCHAIRS, TRANSIT/FOLDING/GLIDEABOUT/ACCESS received FDA 510(k) clearance under submission number K903981, sponsored by D.M.A. , 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 1990-09-17.
- Submission: K903981
- Applicant / Sponsor: D.M.A. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 1990-09-17
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.