510(k) · Cleared
ClearedJWX-1 Plus (Navigo 16/Navigo 24)
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 May 21, 2021 as substantially equivalent to K161241 (Alber GmbH, 2016) and 1 other predicate after a 144-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- May 21, 2021
- Review
- 144 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003449 (2001). 5 ancestors in all, the oldest K001491 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003449 E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs)Ulrich Alber GmbH & Co. · 2001
- 2 generations backK142770 Powered WheelchairAat Alber Antriebstechnik GmbH · 2015
- 1 generation backK161241 e-fix E35/E36Alber GmbH · 2016
- This deviceK203806 JWX-1 Plus (Navigo 16/Navigo 24)Yamaha Motor Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK252101 JWG-1Yamaha Motor Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252101JWG-1Yamaha Motor Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003449 | E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs) | Ulrich Alber GmbH & Co. | 2001 | — |
| −2 | K142770 | Powered Wheelchair | Aat Alber Antriebstechnik GmbH | 2015 | — |
| −1 | K161241 | e-fix E35/E36 | Alber GmbH | 2016 | — |
| 0 (this device) | K203806 | JWX-1 Plus (Navigo 16/Navigo 24) | Yamaha Motor Co., Ltd. | 2021 | — |
| +1 | K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K161241 | e-fix E35/E36Summary page 4…Battery Battery Charger 4. Predicate Device: Alber GmbH e-fix E35/E36 (K161241) YAMAHA MOTOR CO., LTD. JWX-2(K140204) 5. Device Description The JWX-1 PLUS(… | 2016 |
| * | K140204 | JWX-2Summary page 4…4. Predicate Device: Alber GmbH e-fix E35/E36 (K161241) YAMAHA MOTOR CO., LTD. JWX-2(K140204) 5. Device Description The JWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) is an add-on drive for wheelchairs. The JWX-1 PLUS tur… | 2014 |
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 |
|---|---|---|---|
| K252101 | JWG-1 | 2026 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K252101 (Yamaha Motor Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K161241.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 JIWX-1 PLUS( NAVIGO 16"/NAVIGO 24" ) is a Powered Wheelchair Conversion Kit and suitable for a disabled person who can not walk or have restrictions on walking. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.
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/K203806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203806: JWX-1 Plus (Navigo 16/Navigo 24).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203806
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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