510(k) · Cleared
Clearede-fix E35/E36
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alber GmbH · ITI Wheelchair, Powered
Cleared on Oct 5, 2016 as substantially equivalent to K142770 (Aat Alber Antriebstechnik GmbH, 2015) after a 156-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 5, 2016
- Review
- 156 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003449 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003449 E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs)Ulrich Alber GmbH & Co. · 2001
- 1 generation backK142770 Powered WheelchairAat Alber Antriebstechnik GmbH · 2015
- This deviceK161241 e-fix E35/E36Alber GmbH · 2016
- Descendant · cites it directly · 1 of its ownK203806 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003449 | E Motion Wheelchair Drive System (Power-Assist for Manual Wheelchairs) | Ulrich Alber GmbH & Co. | 2001 | — |
| −1 | K142770 | Powered Wheelchair | Aat Alber Antriebstechnik GmbH | 2015 | — |
| 0 (this device) | K161241 | e-fix E35/E36 | Alber GmbH | 2016 | — |
| +1 | K203806 | JWX-1 Plus (Navigo 16/Navigo 24) | Yamaha Motor Co., Ltd. | 2021 | — |
| +1 | K252101 | JWG-1 | Yamaha Motor Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 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? (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 |
|---|---|---|---|
| * | K142770 | Powered WheelchairSummary page 4…1 CFR 890.3860 Classification Panel: Physical Medicine Product Code: ITI Predicate Device Information: K142770 SOLO/SOLO+ (AAT Alber Antriebstechnik GmbH) Indications for Use: The e-fix is an add-on dr… | 2015 |
What descends from it? (2)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203806 (Yamaha Motor Co., Ltd., 2021) has gone furthest, with 1 descendant 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. 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 e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. 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 as stated in the FDA summary.
https://510kreport.com/device/K161241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161241: e-fix E35/E36.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161241
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