# K984354: Mechanical Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Colours 'N Motion
- Decided: Jan 28, 1999 after 55 days
- Product code: IOR (Wheelchair, Mechanical)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Our new Wheelchair, Zephyr is not envisioned nor will it be-marketed to a first time user but rather directed to a handicapped.user who has become relatively proficient in the use of a wheelchair. And who is seeking a lighter and more maneuverable wheelchair for use in sports and athletic enhancement.

Source page: https://510kreport.com/device/K984354
Methodology: https://510kreport.com/methodology