510(k) · Cleared
Recalled · Class II · 2018Tilite YG and Tilite Ygs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tisport · IOR Wheelchair, Mechanical
Cleared on Nov 19, 2002 as substantially equivalent to K890050 (Motion Designs, Inc., 1989) after a 22-day review. Its family tree reaches back 1 generation to 1989. It has been recalled once.
- Decided
- Nov 19, 2002
- Review
- 22 days
- Class
- Class I
- Product code
- IOR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890050 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK890050 Zippie & Quickie 2HP WheelchairMotion Designs, Inc. · 1989
- This deviceK023606 Tilite YG and Tilite YgsTisport · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890050 | Zippie & Quickie 2HP Wheelchair | Motion Designs, Inc. | 1989 | — |
| 0 (this device) | K023606 | Tilite YG and Tilite Ygs | Tisport | 2002 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IOR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IOR device
- #1 K201461 Manual Wheelchair, Model A011score 20.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K890050 | Zippie & Quickie 2HP WheelchairSummary page 2…9- 1 89IOR 9.10. Legally Marketed Predicate Device For Claimed Equivalence: ZippieB Rigid Manual Wheelchair (K890050) 9.11. Description of Device: The TiLite Y G and YGS model wheelchairs are rigid manual titanium wheelchairs. 9.12.… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2018 | Class II | Z-2294-2019 | Component design/selection | The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K890050.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IOR
17so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · IOR
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IOR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IOR
135in 2025
MAUDE reports naming product code IOR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 38 | 1 | 36 |
| 2008 | 13 | 32 | 3 | 62 |
| 2009 | 4 | 43 | 2 | 54 |
| 2010 | 12 | 81 | 0 | 69 |
| 2011 | 6 | 58 | 6 | 232 |
| 2012 | 11 | 176 | 3 | 1,238 |
| 2013 | 7 | 233 | 3 | 4,674 |
| 2014 | 7 | 211 | 3 | 5,082 |
| 2015 | 3 | 104 | 0 | 4,472 |
| 2016 | 10 | 135 | 1 | 1,860 |
| 2017 | 7 | 209 | 0 | 49 |
| 2018 | 3 | 203 | 0 | 58 |
| 2019 | 6 | 160 | 0 | 53 |
| 2020 | 2 | — | 0 | 43 |
| 2021 | 2 | — | 1 | 59 |
| 2022 | 4 | 150 | 0 | 37 |
| 2023 | 9 | 61 | 0 | 165 |
| 2024 | 4 | 65 | 0 | 138 |
| 2025 | 7 | 91 | 0 | 135 |
| 2026 | 17 | 103 | 0 | — |
What is it indicated for?
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…
Read the full statement (146 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023606: Tilite YG and Tilite Ygs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023606
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026