# K023606: Tilite YG and Tilite Ygs

- Pathway: 510(k) (Traditional)
- Applicant: Tisport
- Decided: Nov 19, 2002 after 22 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890050 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890050: Zippie & Quickie 2HP Wheelchair, Motion Designs, Inc. (1989) Summary page 2.

## Recalls of this device
- Sep 11, 2018 · Class II · Z-2294-2019: The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.

## Indications for use
The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie@ (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows. This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions: - Amputee; - Arthritis; - Arthrogriposis; - Cerebral Palsy; - geriatric conditions; - head injury or trauma; - hemiplegic; - Multiple Sclerosis; - Muscular Dystrophy; - paraplegic; - Polio; - quadraplegic; - Spina Bifida; - StokeICVA; - tetraplegic; and - other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis

Source page: https://510kreport.com/device/K023606
Methodology: https://510kreport.com/methodology