# K020100: SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 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 SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 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/K020100
Methodology: https://510kreport.com/methodology