510(k) · Cleared
ClearedTisport X and Tisport XC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tisport · IOR Wheelchair, Mechanical
Cleared on Mar 22, 1999 as substantially equivalent to K890050 (Motion Designs, Inc., 1989) after a 28-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 22, 1999
- Review
- 28 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- 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 deviceK990555 Tisport X and Tisport XCTisport · 1999
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) | K990555 | Tisport X and Tisport XC | Tisport | 1999 | — |
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 1…Panel: Physical Medicine Device Prosthetic Devices Subpart D Product Code: 89I0R (Mechanical Wheelchair) Legally Marketed Dévice Claiming Equivalence To: Quickie 2HP (K890050) Description of Device: The TiSport X and XC manual titanium wheelchairs are folding everyday chairs. Intended Use of the Devic… | 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)
No FDA recall names this device.
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 (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going “everyday” use.
The specific medical conditions for which the device is indicated are listed as, but not limited to:
Spinal chord injury
Stoke/CVA
Post Polio Syndrome
Spina Bifada
Amputee
Multiple Sclerosis
Arthrogriposis
Muscular Dystrophy
Lower and upper extremity paralysis
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990555: Tisport X and Tisport XC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990555
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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