510(k) · Cleared
ClearedAction Storm Ranger II, Action Storm Power 9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invacare Corp. · ITI Wheelchair, Powered
Cleared on Oct 5, 1998 as substantially equivalent to K960951 (Permobil AB, 1997) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 1990. 18 later devices descend from it.
- Decided
- Oct 5, 1998
- Review
- 115 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900565 (1990). 2 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK900565 Invacare Power 9000 Series WheelchairInvacare Corp. · 1990
- This deviceK982064 Action Storm Ranger II, Action Storm Power 9000Invacare Corp. · 1998
- Descendant · cites it directly · 17 of its ownK991168 Arrow FWD Power WheelchairInvacare Corp. · 1999 · Recalled
- Descendant · 2 generations on · 14 of its ownK012909 Xterra GT Power WheelchairInvacare Corp. · 2001
- Descendant · 2 generations on · 9 of its ownK023589 Storm TDX Power WheelchairInvacare Corp. · 2002 · Recalled
- Descendant · 3 generations on · 4 of its ownK141783 TDX SP2 Power WheechairInvacare Corporation · 2015
- Descendant · 4 generations on · 3 of its ownK170507 Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX…Invacare Corporation · 2017 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K991168Arrow FWD Power WheelchairInvacare Corp. · 1999 · cites it directly17descendants
- K012909Xterra GT Power WheelchairInvacare Corp. · 2001 · 2 generations on14descendants
- K023589Storm TDX Power WheelchairInvacare Corp. · 2002 · 2 generations on9descendants
- K141783TDX SP2 Power WheechairInvacare Corporation · 2015 · 3 generations on4descendants
- K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…Invacare Corporation · 2017 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900565 | Invacare Power 9000 Series Wheelchair | Invacare Corp. | 1990 | — |
| 0 (this device) | K982064 | Action Storm Ranger II, Action Storm Power 9000 | Invacare Corp. | 1998 | — |
| +1 | K991168 | Arrow FWD Power Wheelchair | Invacare Corp. | 1999 | 2 |
| +2 | K012909 | Xterra GT Power Wheelchair | Invacare Corp. | 2001 | — |
| +2 | K023589 | Storm TDX Power Wheelchair | Invacare Corp. | 2002 | 7 |
| +3 | K141783 | TDX SP2 Power Wheechair | Invacare Corporation | 2015 | — |
| +4 | K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics… | Invacare Corporation | 2017 | 2 |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K960951 | Permobil Chairman L/CS 8Summary page 2…, Powered Predicate Devices The Models Ranger II and Power 9000 Front Wheel Drive power wheelchairs are substantially equivalent to Permobil’s Chairman (K960951, April 4, 1997) Front Wheel Drive Power Wheelchair and Invacare Power 9000 (K900565, February 2, 1990) power wheelchairs. The whe… | 1997 |
| * | K900565 | Invacare Power 9000 Series WheelchairSummary page 2…t Wheel Drive power wheelchairs are substantially equivalent to Permobil’s Chairman (K960951, April 4, 1997) Front Wheel Drive Power Wheelchair and Invacare Power 9000 (K900565, February 2, 1990) power wheelchairs. The wheelchairs are controlled using the Invacare Model MCC-MKIV RII Motor Controller and-J… | 1990 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991168 | Arrow FWD Power Wheelchair | 1999 | 17 |
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?
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?
To provide mobility to persons limited to a seated position.
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/K982064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982064: Action Storm Ranger II, Action Storm Power 9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982064
Report an extraction error
Are you the manufacturer?
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