# K103212: Roughrider

- Pathway: 510(k) (Traditional)
- Applicant: Whirlwind Wheelchair International
- Decided: Jan 3, 2011 after 63 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K200715: RoughRider Aurora Manual Wheelchair (2022), 0 descendants of its own

## Indications for use
The RoughRider is indicated to provide mobility to persons restricted to a seated position. The wheelchair is indicated for a weight capacity of up to 220 lbs.

Source page: https://510kreport.com/device/K103212
Methodology: https://510kreport.com/methodology
