# K020094: EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchairs

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Insight, Inc.
- Decided: Mar 8, 2002 after 56 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
The EN 600-658, EN 600-666, EN 600-664, EN-600-690, EN 600-651, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchairs are manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K020094
Methodology: https://510kreport.com/methodology