510(k) · Cleared
ClearedGen_2 Mechanical Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Free Wheelchair Mission · IOR Wheelchair, Mechanical
Cleared on May 7, 2012 as substantially equivalent to K062660 (Ki Mobility, LLC, 2006) after a 140-day review. Its family tree reaches back 2 generations to 1985. 3 later devices descend from it.
- Decided
- May 7, 2012
- Review
- 140 days
- Class
- Class I
- Product code
- IOR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850536 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK850536 Quickie WheelchairsMotion Designs, Inc. · 1985
- 1 generation backK062660 CatalysyKi Mobility, LLC · 2006
- This deviceK113713 Gen_2 Mechanical WheelchairFree Wheelchair Mission · 2012
- Descendant · cites it directly · 2 of its ownK141691 GEN_3Free Wheelchair Mission · 2014
- Descendant · 2 generations on · 0 of its ownK252370 GEN 4 JOY WheelchairFree Wheelchair Mission · 2026
- Descendant · cites it directly · 0 of its ownK170701 GEN_2 and GEN_3 Mechanical WheelchairsFree Wheelchair Mission · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850536 | Quickie Wheelchairs | Motion Designs, Inc. | 1985 | — |
| −1 | K062660 | Catalysy | Ki Mobility, LLC | 2006 | — |
| 0 (this device) | K113713 | Gen_2 Mechanical Wheelchair | Free Wheelchair Mission | 2012 | — |
| +1 | K141691 | GEN_3 | Free Wheelchair Mission | 2014 | — |
| +2 | K252370 | GEN 4 JOY Wheelchair | Free Wheelchair Mission | 2026 | — |
| +1 | K170701 | GEN_2 and GEN_3 Mechanical Wheelchairs | Free Wheelchair Mission | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K062660 | CatalysySummary page 1…ommon Name: Mechanical Wheelchair Classification Name: Mechanical wheelchair per 21 CFR 890.3850, IOR Predicate Devices: Ki Mobility Catalyst Wheelchair, K062660 Device Description: The GEN_2 mechanical wheelchair is a highly adaptable all- purpose wheelchair crea… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141691 (Free Wheelchair Mission, 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IOR devicesIOR Wheelchair, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 GEN_2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113713: Gen_2 Mechanical Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113713
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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