# K990358: Cross Sport, Rigid Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Tisport
- Decided: Feb 26, 1999 after 21 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925451 (1993). 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)
- K925451: Shadow Rigid Wheelchair, Magic-In-Motion, Inc. (1993) Summary page 1.

## Most influential descendants
- K024055: Tilite Evo (2002), 0 descendants of its own

## Recalls of this device
- Sep 24, 2021 · Class II · Z-0264-2022: Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor veh
- Sep 11, 2018 · Class II · Z-2294-2019: The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.
- Jul 5, 2011 · Not classified · Z-3161-2011: The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.

## Indications for use
The intended use of this device (manual wheelchair) is the same as the predicate device (Shadow rigid wheelchair {K925451} by Magic In Motion now owned by Quickie). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going “everyday” use and/or recreational sports applications. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Post polio Spina Bifada Amputee

Source page: https://510kreport.com/device/K990358
Methodology: https://510kreport.com/methodology