# K974197: Elite Lightweight Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Jaken Co., Inc.
- Decided: Dec 17, 1997 after 40 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 K930412 (1993). 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)
- K930412: Premier 2 Wheelchair, Everest & Jennings, Inc. (1993) Summary page 3.

## Indications for use
OUR ELITE LIGHTWEIGHT WHEELCHAIR IS A MECHANICAL DEVICE THAT TRANSPORT OCCUPANTS WHO ARE IMMOBILE FROM ONE LOCATION TO ANOTHER. IN ORDER FOR ONE TO OPERATE THIS DEVICE AN ASSISTANT CAN PUSH THE WHEELCHAIR FROM BEHIND USING THE HANDLE BARS OR IF THE OCCUPANT HAS FUNCTION OF HIS/HER UPPER TORSO THEY CAN WHEEL THEMSELVES AROUND BY USING THE HANDRIMS THAT IS ATTACHED TO THE WHEELS.

Source page: https://510kreport.com/device/K974197
Methodology: https://510kreport.com/methodology