# K120391: MR4500 Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Wardray Premise, Ltd.
- Decided: Dec 21, 2012 after 318 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
Longest line of descent: 1 generation back to K935398 (1994). 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)
- K935398: Tracer Series Manual Wheelchairs, Invacare Corp. (1994) Summary page 1.

## Indications for use
The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.

Source page: https://510kreport.com/device/K120391
Methodology: https://510kreport.com/methodology