Cross Sport, Rigid Wheelchair

510(k) K990358

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK990358	Date26 Feb 1999Cleared	StatusActive

3 recalls · 1 ongoing · FDA

- Ongoing Z-0264-2022 FDA Class II initiated 24 Sep 2021
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 vehicle accident. Some affected wheelchairs can no longer be used as a passenger seat until transit tie downs are replaced with redesigned transit tie downs, verified, and released to the market.
- Terminated Z-2294-2019 FDA Class II initiated 11 Sep 2018
The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.
- Terminated Z-3161-2011 FDA Unclassified (pre-2012) initiated 5 Jul 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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)