510(k) · Cleared
Recalled · Class I · 2025SmartDrive Wheelchair Power Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Max Mobility, LLC · ITI Wheelchair, Powered
Cleared on Jul 30, 2015 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 9 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it. It has been recalled 7 times, including 5 Class I recalls.
- Decided
- Jul 30, 2015
- Review
- 86 days
- Class
- Class II
- Product code
- ITI
- Recalls
- 7 (5 Class I)
- Predicates
- 0
8 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- This deviceK151199 SmartDrive Wheelchair Power AssistMax Mobility, LLC · 2015
- Descendant · cites it directly · 6 of its ownK192016 Smoov O10Alber GmbH · 2020
- Descendant · 2 generations on · 1 of its ownK240267 Klaxon (Twist); Klaxon (Twist R)Klaxon Mobility GmbH · 2025
- Descendant · 2 generations on · 1 of its ownK222502 Klick (Variants: Power, Race, Monster)Klaxon Mobility GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK192618 e-Motion M25Alber GmbH · 2020
- Descendant · 3 generations on · 0 of its ownK250748 Klaxon (Twist); Klaxon (Twist R)Klaxon-Mobility GmbH · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K192016Smoov O10Alber GmbH · 2020 · cites it directly6descendants
- K240267Klaxon (Twist); Klaxon (Twist R)Klaxon Mobility GmbH · 2025 · 2 generations on1descendant
- K222502Klick (Variants: Power, Race, Monster)Klaxon Mobility GmbH · 2022 · 2 generations on1descendant
- K192618e-Motion M25Alber GmbH · 2020 · 2 generations on1descendant
- K250748Klaxon (Twist); Klaxon (Twist R)Klaxon-Mobility GmbH · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K151199 | SmartDrive Wheelchair Power Assist | Max Mobility, LLC | 2015 | — |
| +1 | K192016 | Smoov O10 | Alber GmbH | 2020 | — |
| +2 | K240267 | Klaxon (Twist); Klaxon (Twist R) | Klaxon Mobility GmbH | 2025 | — |
| +2 | K222502 | Klick (Variants: Power, Race, Monster) | Klaxon Mobility GmbH | 2022 | — |
| +2 | K192618 | e-Motion M25 | Alber GmbH | 2020 | — |
| +3 | K250748 | Klaxon (Twist); Klaxon (Twist R) | Klaxon-Mobility GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2025 | Class I | Z-2538-2025 | Component design/selection | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. |
| Aug 12, 2025 | Class I | Z-2540-2025 | Component design/selection | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. |
| Aug 12, 2025 | Class I | Z-2539-2025 | Component design/selection | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries. |
| Dec 20, 2024 | Class I | Z-1117-2025 | Component change control | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries. |
| Dec 20, 2024 | Class I | Z-1116-2025 | Component change control | Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries. |
| May 10, 2023 | Class II | Z-2004-2023 | Software design | When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the… |
| May 10, 2023 | Class II | Z-2005-2023 | Software design | When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192016 (Alber GmbH, 2020) has gone furthest, with 6 descendants 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. 2015, 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 SmartDrive MX2 Wheelchair Power Assist is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users, including pediatrics. It is intended to be used by users capable of operating and maneuvering a powered and manual wheelchair.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K151199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151199: SmartDrive Wheelchair Power Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151199
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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