510(k) · Cleared
Recalled · Class II · 2015Storm TDX 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 Nov 19, 2002 as substantially equivalent to K991168 (Invacare Corp., 1999) and 2 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1990. 9 later devices descend from it. It has been recalled 7 times.
- Decided
- Nov 19, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 4 generations to K900565 (1990). 5 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- 3 generations backK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- 2 generations backK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
- 1 generation backK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
- This deviceK023589 Storm TDX Power WheelchairInvacare Corp. · 2002
- Descendant · cites it directly · 4 of its ownK141783 TDX SP2 Power WheechairInvacare Corporation · 2015
- Descendant · 2 generations on · 3 of its ownK170507 Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX…Invacare Corporation · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK192216 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK092225 Amypower All Track Series Power WheelchairAmylior, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK073701 Dane Technologies Wheelchair Mover, Model WM 2000Dane Technologies · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K141783TDX SP2 Power WheechairInvacare Corporation · 2015 · cites it directly4descendants
- K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…Invacare Corporation · 2017 · 2 generations on3descendants
- K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPInvacare Corporation · 2020 · 3 generations on1descendant
- K092225Amypower All Track Series Power WheelchairAmylior, Inc. · 2009 · cites it directly1descendant
- K073701Dane Technologies Wheelchair Mover, Model WM 2000Dane Technologies · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| −3 | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| −2 | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | 2 |
| −1 | K012909 | Xterra GT Power Wheelchair | Invacare Corp. | 2001 | — |
| 0 (this device) | K023589 | Storm TDX Power Wheelchair | Invacare Corp. | 2002 | — |
| +1 | K141783 | TDX SP2 Power Wheechair | Invacare Corporation | 2015 | — |
| +2 | K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics… | Invacare Corporation | 2017 | 2 |
| +3 | K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | Invacare Corporation | 2020 | 1 |
| +1 | K092225 | Amypower All Track Series Power Wheelchair | Amylior, Inc. | 2009 | — |
| +1 | K073701 | Dane Technologies Wheelchair Mover, Model WM 2000 | Dane Technologies | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K991168 | Arrow FWD Power WheelchairSummary page 1…al Name Power Wheelchair Classification Name Wheelchair, Powered Predicate Devices Invacare Corporations’ Action Arrow Front Wheel Drive Power Wheelchairs (K99 1 168 June 25, 1999), Xterra GT Power Wheelchair (KO 12909, 10/24/2001) and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K96… | 1999 |
| * | K012909 | Xterra GT Power WheelchairSummary page 2…alent to these devices are Invacare Corporations’ Action Arrow Front Wheel Drive Power Wheelchairs (K991168, June 25, 1999), Invacare’s Model Xterra GT Power Wheelchair (K012909, 10/24/2001), and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997). PERFORMANCE DATA As required… | 2001 |
| * | K960951 | Permobil Chairman L/CS 8Summary page 1…nt Wheel Drive Power Wheelchairs (K99 1 168 June 25, 1999), Xterra GT Power Wheelchair (KO 12909, 10/24/2001) and Permobil’s Chairman Front Wheel Drive Power Wheelchair (K96095 1, April 4, 1997). Intended Use The intended use of the Invacare Model Storm TDX Power Wheelchair is to provide mobility to person… | 1997 |
What descends from it? (9)
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-1137-2015 | 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… |
| Jun 4, 2013 | Class II | Z-2270-2013 | Process control | Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks. |
| Apr 6, 2012 | Class II | Z-1905-2012 | Employee error | Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which… |
| Feb 10, 2012 | Not classified | Z-1201-2012 | Nonconforming Material/Component | Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires. |
| Sep 15, 2009 | Not classified | Z-0579-2010 | Device Design | For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock… |
| Nov 27, 2007 | Not classified | Z-0930-2009 | Pending | Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward… |
| Mar 19, 2007 | Not classified | Z-0966-2007 | Other | Software error may permit the chair to recline too far. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K141783 (Invacare Corporation, 2015) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K991168.
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 intended use of the Invacare Model Sform TDX Power Wheelchair is to provide mobility to persons limited to a sittrng posihon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023589: Storm TDX 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/K023589
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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