# K130644: Pediatric Folding Wheelchair

- Pathway: 510(k) (Abbreviated)
- Applicant: Columbia Medical Mfg, LLC
- Decided: Oct 16, 2013 after 219 days
- Product code: LBE (Stroller, Adaptive)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810676 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810676: Convaid Cruiser CP4M, Convaid Products, Inc. (1981) Summary page 1.

## Indications for use
The Columbia Medical Pediatric Folding Wheelchair is a manually propelled wheelchair designed to provide mobility aid for children and adolescents who have limited or no ability to ambulate and require a device to aid in seated mobility in the home and community.

Source page: https://510kreport.com/device/K130644
Methodology: https://510kreport.com/methodology