510(k) · Cleared
Recalled · 2005Quickie Freestyle Power Wheelchair, Model G-424
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical, Inc. · ITI Wheelchair, Powered
Cleared on May 9, 2003 after a 16-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled once.
- Decided
- May 9, 2003
- Review
- 16 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK031289 Quickie Freestyle Power Wheelchair, Model G-424Sunrise Medical, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK051387 Levo Comfort IILevo AG · 2005
- Descendant · 2 generations on · 4 of its ownK083017 LEVO C3Levo AG · 2008
- Descendant · 3 generations on · 2 of its ownK172384 Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018
- Descendant · 2 generations on · 1 of its ownK060936 ParagolferParabasetec, GmbH · 2006
- Descendant · 4 generations on · 0 of its ownK233877 XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K051387Levo Comfort IILevo AG · 2005 · cites it directly9descendants
- K083017LEVO C3Levo AG · 2008 · 2 generations on4descendants
- K172384Quickie (r) Q700-UP MSunrise Medical (Us), LLC · 2018 · 3 generations on2descendants
- K060936ParagolferParabasetec, GmbH · 2006 · 2 generations on1descendant
- K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031289 | Quickie Freestyle Power Wheelchair, Model G-424 | Sunrise Medical, Inc. | 2003 | — |
| +1 | K051387 | Levo Comfort II | Levo AG | 2005 | — |
| +2 | K083017 | LEVO C3 | Levo AG | 2008 | — |
| +3 | K172384 | Quickie (r) Q700-UP M | Sunrise Medical (Us), LLC | 2018 | — |
| +2 | K060936 | Paragolfer | Parabasetec, GmbH | 2006 | — |
| +4 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051387 | Levo Comfort II | 2005 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2005 | Not classified | Z-0518-06 | Other | While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051387 (Levo AG, 2005) has gone furthest, with 9 descendants of its own.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The Center Drive Power Wheelchair’s intended use is to empower physically challenged individuals by providing a means of mobility.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031289: Quickie Freestyle Power Wheelchair, Model G-424.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031289
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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