510(k) · Cleared
ClearedJWX-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yamaha Motor Co., Ltd. · ITI Wheelchair, Powered
Cleared on Aug 28, 2014 as substantially equivalent to K001491 (Sunrise Medical, Inc., 2000) and 1 other predicate after a 213-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Aug 28, 2014
- Review
- 213 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001491 (2000). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001491 Quickie 2 Power Assist WheelchairSunrise Medical, Inc. · 2000
- This deviceK140204 JWX-2Yamaha Motor Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK151717 twionAlber GmbH · 2016
- Descendant · cites it directly · 1 of its ownK203806 JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK192618 e-Motion M25Alber GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK252101 JWG-1Yamaha Motor Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK221215 e-motion M25Alber GmbH · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151717twionAlber GmbH · 2016 · cites it directly2descendants
- K203806JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 2021 · cites it directly1descendant
- K192618e-Motion M25Alber GmbH · 2020 · 2 generations on1descendant
- K252101JWG-1Yamaha Motor Co., Ltd. · 2026 · 2 generations on0descendants
- K221215e-motion M25Alber GmbH · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001491 | Quickie 2 Power Assist Wheelchair | Sunrise Medical, Inc. | 2000 | — |
| 0 (this device) | K140204 | JWX-2 | Yamaha Motor Co., Ltd. | 2014 | — |
| +1 | K151717 | twion | Alber GmbH | 2016 | — |
| +1 | K203806 | JWX-1 Plus (Navigo 16/Navigo 24) | Yamaha Motor Co., Ltd. | 2021 | — |
| +2 | K192618 | e-Motion M25 | Alber GmbH | 2020 | — |
| +2 | K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026 | — |
| +3 | K221215 | e-motion M25 | Alber GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K001491 | Quickie 2 Power Assist WheelchairSummary page 5…ission: New device design 5. Predicate Device: SUNRISE MEDICAL, INC. QUICKIE 2 POWER ASSIST WHEELCHAIR(K001491) Urich Alber GmbH & Co. KG e‐motion Wheelchair Dri… | 2000 |
| * | K003449 | E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs)Summary page 5…WER ASSIST WHEELCHAIR(K001491) Urich Alber GmbH & Co. KG e‐motion Wheelchair Drive System (K003449) 6. Device Description The device JWX‐2 is an electric power assist unit for wheelchairs that turns a manual wheelchai… | 2001 |
What descends from it? (6)
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)
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. 2014, this device’s year, is highlighted.
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 device JWX-2 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140204: JWX-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140204
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