510(k) · Cleared
ClearedExtreme X8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magic Mobility · ITI Wheelchair, Powered
Cleared on Jul 9, 2021 as substantially equivalent to K090350 (Vestil Manufacturing Corp., 2009) after a 49-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jul 9, 2021
- Review
- 49 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000796 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK000796 Magic Mobility 4 X 4 WheelchairVestil Manufacturing Corp. · 2000
- 1 generation backK090350 Extreme 4X4-X8 Power WheelchairVestil Manufacturing Corp. · 2009
- This deviceK211574 Extreme X8Magic Mobility · 2021
- Descendant · cites it directly · 0 of its ownK233877 XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024
Most influential descendants
Showing 1 of 1 · See all- K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)Magic Mobility · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000796 | Magic Mobility 4 X 4 Wheelchair | Vestil Manufacturing Corp. | 2000 | — |
| −1 | K090350 | Extreme 4X4-X8 Power Wheelchair | Vestil Manufacturing Corp. | 2009 | — |
| 0 (this device) | K211574 | Extreme X8 | Magic Mobility | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K090350 | Extreme 4X4-X8 Power WheelchairSummary page 4…Power Wheelchair is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate Relationship K090350 Extreme 4x4-X8 / Innovation In Motion Predicate Device K172384 Quickie® Q700-UP M / Sunrise… | 2009 |
| † | K172384 | Quickie (r) Q700-UP M | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | 2024 | 0 |
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 21 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233877 (Magic Mobility, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090350.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.
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/K211574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211574: Extreme X8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211574
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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