510(k) · Cleared
ClearedQuickie 2 Power Assist Wheelchair
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunrise Medical, Inc. · ITI Wheelchair, Powered
Cleared on Dec 15, 2000 after a 217-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 15, 2000
- Review
- 217 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK001491 Quickie 2 Power Assist WheelchairSunrise Medical, Inc. · 2000
- Descendant · cites it directly · 6 of its ownK140204 JWX-2Yamaha Motor Co., Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK151717 twionAlber GmbH · 2016
- Descendant · 2 generations on · 1 of its ownK203806 JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK192618 e-Motion M25Alber GmbH · 2020
- Descendant · 3 generations on · 0 of its ownK252101 JWG-1Yamaha Motor Co., Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K140204JWX-2Yamaha Motor Co., Ltd. · 2014 · cites it directly6descendants
- K151717twionAlber GmbH · 2016 · 2 generations on2descendants
- K203806JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 2021 · 2 generations on1descendant
- K192618e-Motion M25Alber GmbH · 2020 · 3 generations on1descendant
- K252101JWG-1Yamaha Motor Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001491 | Quickie 2 Power Assist Wheelchair | Sunrise Medical, Inc. | 2000 | — |
| +1 | K140204 | JWX-2 | Yamaha Motor Co., Ltd. | 2014 | — |
| +2 | K151717 | twion | Alber GmbH | 2016 | — |
| +2 | K203806 | JWX-1 Plus (Navigo 16/Navigo 24) | Yamaha Motor Co., Ltd. | 2021 | — |
| +3 | K192618 | e-Motion M25 | Alber GmbH | 2020 | — |
| +3 | K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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? (8)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140204 (Yamaha Motor Co., Ltd., 2014) has gone furthest, with 6 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/K001491 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001491: Quickie 2 Power Assist Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001491
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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