510(k) · Cleared
ClearedExtreme 4X4-X8 Power Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vestil Manufacturing Corp. · ITI Wheelchair, Powered
Cleared on Apr 10, 2009 as substantially equivalent to K000796 (Vestil Manufacturing Corp., 2000) after a 58-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Apr 10, 2009
- Review
- 58 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000796 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000796 Magic Mobility 4 X 4 WheelchairVestil Manufacturing Corp. · 2000
- This deviceK090350 Extreme 4X4-X8 Power WheelchairVestil Manufacturing Corp. · 2009
- Descendant · cites it directly · 1 of its ownK211574 Extreme X8Magic Mobility · 2021
- Descendant · 2 generations on · 0 of its ownK233877 XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024
- Descendant · cites it directly · 0 of its ownK152672 Cajun Commando 4x4Lil Critter, LLC · 2016
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 |
|---|---|---|---|---|---|
| −1 | K000796 | Magic Mobility 4 X 4 Wheelchair | Vestil Manufacturing Corp. | 2000 | — |
| 0 (this device) | K090350 | Extreme 4X4-X8 Power Wheelchair | Vestil Manufacturing Corp. | 2009 | — |
| +1 | K211574 | Extreme X8 | Magic Mobility | 2021 | — |
| +2 | K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | 2024 | — |
| +1 | K152672 | Cajun Commando 4x4 | Lil Critter, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K000796 | Magic Mobility 4 X 4 WheelchairSummary page 2…on names: Device Name: Extreme 4x4- X8 Common Name: Power Wheelchair Classification Name: Restorative Devices Predicate Device: Extreme 4x4- X4 (K000796) Device Description: The Extreme 4x4- X8 is a battery powered, electric motor driven device with the intended function of provi… | 2000 |
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?
- Its one ancestor has no recall.
- Of its descendants, K211574 (Magic Mobility, 2021) has gone furthest, with 1 descendant 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. 2009, this device’s year, is highlighted.
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?
This device is an electric powered wheelchair for indoor and/or outdoor use, to be used by partially disabled individuals capable of operating a few essential hand controls.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090350 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090350: Extreme 4X4-X8 Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090350
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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