510(k) · Cleared
ClearedChoice Powered Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Technology, Inc. · ITI Wheelchair, Powered
Cleared on Feb 12, 1997 as substantially equivalent to K900330 (Quickie Designs, Inc., 1990) and 1 other predicate after a 142-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Feb 12, 1997
- Review
- 142 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900330 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K031711Tango, Models, BP1American Bantex Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900330 | Quickie P300 Wheelchair | Quickie Designs, Inc. | 1990 | — |
| 0 (this device) | K963808 | Choice Powered Wheelchair | American Medical Technology, Inc. | 1997 | — |
| +1 | K031711 | Tango, Models, BP1 | American Bantex Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K900330 | Quickie P300 WheelchairSummary page 1…rican Medical Technologies as well as numerous other devices such as the Permobil, Inc. ‘Chairman’ power wheelchair, the Sunrise Medical ‘Quickie P300" power wheelchair [K900330] and the Invacare ‘Action Storm’ power wheelchair [K940051]. Description of the new device The CHOICE powered wheelchair is man… | 1990 |
| * | K940051 | Action Storm Power WheelchairSummary page 1…s such as the Permobil, Inc. ‘Chairman’ power wheelchair, the Sunrise Medical ‘Quickie P300" power wheelchair [K900330] and the Invacare ‘Action Storm’ power wheelchair [K940051]. Description of the new device The CHOICE powered wheelchair is manufactured using fabricated steel for the power base and sea… | 1994 |
| * | — | EXCELSIOR SR powered wheelchair Named without a submission number | |
| * | — | ‘Chairman’ power wheelchair Named without a submission number |
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 |
|---|---|---|---|
| K031711 | Tango, Models, BP1 | 2003 | 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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K031711 (American Bantex Corp., 2003) has gone furthest, with 0 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 | — |
What is it indicated for?
The CHOICE powered wheelchair is intended to provide mobility for a person who, due to medical reasons, the debilitating nature of some illnesses, because of accident, injury and/or subsequent paralysis, is either missing or unable to use the lower extremities. Some, but not all of the specific indications for use of a power wheelchair are: paraplegia, quadriplegia, ALS, muscular dystrophy, muscular sclerosis, lower limb amputation and any one or more of numerous neurological or muscular diseases which render the limbs too weak or unstable for normal use.
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/K963808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963808: Choice Powered Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963808
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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