510(k) · Cleared
Clearede-motion M25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alber GmbH · ITI Wheelchair, Powered
Cleared on May 24, 2022 as substantially equivalent to K192618 (Alber GmbH, 2020) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 2000. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- May 24, 2022
- Review
- 27 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001491 (2000). 7 ancestors in all. No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK001491 Quickie 2 Power Assist WheelchairSunrise Medical, Inc. · 2000
- 3 generations backK140204 JWX-2Yamaha Motor Co., Ltd. · 2014
- 2 generations backK151717 twionAlber GmbH · 2016
- 1 generation backK192618 e-Motion M25Alber GmbH · 2020
- This deviceK221215 e-motion M25Alber GmbH · 2022
Class I recalls in this family
- K151199 SmartDrive Wheelchair Power Assist2 generations back · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001491 | Quickie 2 Power Assist Wheelchair | Sunrise Medical, Inc. | 2000 | — |
| −3 | K140204 | JWX-2 | Yamaha Motor Co., Ltd. | 2014 | — |
| −2 | K151717 | twion | Alber GmbH | 2016 | — |
| −1 | K192618 | e-Motion M25 | Alber GmbH | 2020 | — |
| 0 (this device) | K221215 | e-motion M25 | Alber GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2015 | 1 | 1 |
| 2020 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K192618 | e-Motion M25Summary page 4…ication Panel: Physical Medicine Product Code: ITI Predicate Device: 510(k): K192618 Proprietary: e-motion M25… | 2020 |
| * | K192016 | Smoov O10Summary page 4…ication Panel: Physical Medicine Product Code: ITI Secondary Predicate Device: 510(k): K192016 Proprietary: SMOOV O10… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K151199SmartDrive Wheelchair Power AssistMax Mobility, LLC · 2015 · 2 generations back · ◆ in the 2015 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 7 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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-motion M25 DuoDrive 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221215: e-motion M25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221215
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