# K200715: RoughRider Aurora Manual Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Roughrider America, LLC
- Decided: Jun 24, 2022 after 828 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: 2 generations back to K935398 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103212: Roughrider, Whirlwind Wheelchair International (2011) Summary page 5.

## Indications for use
The RoughRider Americam RoughRider Auroram Manual Wheelchair is indicated to provide mobility to persons restricted to a seated position up to a weight capacity of up to 250 lb / 114 kg.

Source page: https://510kreport.com/device/K200715
Methodology: https://510kreport.com/methodology