510(k) · Cleared
Clearedtwion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alber GmbH · ITI Wheelchair, Powered
Cleared on Feb 23, 2016 as substantially equivalent to K140204 (Yamaha Motor Co., Ltd., 2014) after a 243-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Feb 23, 2016
- Review
- 243 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001491 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001491 Quickie 2 Power Assist WheelchairSunrise Medical, Inc. · 2000
- 1 generation backK140204 JWX-2Yamaha Motor Co., Ltd. · 2014
- This deviceK151717 twionAlber GmbH · 2016
- Descendant · cites it directly · 1 of its ownK192618 e-Motion M25Alber GmbH · 2020
- Descendant · 2 generations on · 0 of its ownK221215 e-motion M25Alber GmbH · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001491 | Quickie 2 Power Assist Wheelchair | Sunrise Medical, Inc. | 2000 | — |
| −1 | K140204 | JWX-2 | Yamaha Motor Co., Ltd. | 2014 | — |
| 0 (this device) | K151717 | twion | Alber GmbH | 2016 | — |
| +1 | K192618 | e-Motion M25 | Alber GmbH | 2020 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K140204 | JWX-2Summary page 4…ITI Classification Panel: Physical Medicine 5. Predicate Device: The twion device is substantially equivalent to the Yamaha JWX-2 device (K140204). FDA granted 510(k) clearance for this predicate device on August 28, 2014 under K140204. 6. Device Description The twi… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192618 | e-Motion M25 | 2020 | 1 |
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 16 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K192618 (Alber GmbH, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K140204.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 twion 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/K151717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151717: twion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151717
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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