510(k) · Cleared
Recalled · Class II · 2015Action Storm Power Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · ITI Wheelchair, Powered
Cleared on Mar 28, 1994 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 28, 1994
- Review
- 82 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK940051 Action Storm Power WheelchairInvacare Corp. · 1994
- Descendant · cites it directly · 2 of its ownK993413 Storm Series, Power 9000 Series and Power Tiger with Gyroscope ControlInvacare Corp. · 1999 · Recalled
- Descendant · cites it directly · 1 of its ownK092225 Amypower All Track Series Power WheelchairAmylior, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK963808 Choice Powered WheelchairAmerican Medical Technology, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK193599 BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair…21st Century Scientific, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK042699 Ability Power GurneyGator Custom Mobility, Inc. · 2005
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K993413Storm Series, Power 9000 Series and Power Tiger with Gyroscope ControlInvacare Corp. · 1999 · cites it directly2descendants
- K092225Amypower All Track Series Power WheelchairAmylior, Inc. · 2009 · cites it directly1descendant
- K963808Choice Powered WheelchairAmerican Medical Technology, Inc. · 1997 · cites it directly1descendant
- K193599BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power…21st Century Scientific, Inc. · 2020 · 2 generations on0descendants
- K042699Ability Power GurneyGator Custom Mobility, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940051 | Action Storm Power Wheelchair | Invacare Corp. | 1994 | — |
| +1 | K993413 | Storm Series, Power 9000 Series and Power Tiger with Gyroscope Control | Invacare Corp. | 1999 | 2 |
| +1 | K092225 | Amypower All Track Series Power Wheelchair | Amylior, Inc. | 2009 | — |
| +1 | K963808 | Choice Powered Wheelchair | American Medical Technology, Inc. | 1997 | — |
| +2 | K193599 | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450… | 21st Century Scientific, Inc. | 2020 | — |
| +2 | K042699 | Ability Power Gurney | Gator Custom Mobility, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2015 | Class II | Z-1139-2015 | Device Design | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993413 (Invacare Corp., 1999) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K940051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940051: Action Storm Power Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940051
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026