Clearance Summary
PEDIATRIC FOLDING WHEELCHAIR received FDA 510(k) clearance under submission number K130644, sponsored by Columbia Medical Mfg, LLC. 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 2013-10-16.
- Submission: K130644
- Applicant / Sponsor: Columbia Medical Mfg, LLC
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3850
- Decision date: 2013-10-16
Classification & Regulation
This clearance is catalogued under FDA product code LBE and 21 CFR 890.3850, within the Physical Medicine review panel as a Class I device.