# K151199: SmartDrive Wheelchair Power Assist

- Pathway: 510(k) (Traditional)
- Applicant: Max Mobility, LLC
- Decided: Jul 30, 2015 after 86 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: 7 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192016: Smoov O10 (2020), 6 descendants of its own
- K240267: Klaxon (Twist); Klaxon (Twist R) (2025), 1 descendant of its own
- K222502: Klick (Variants: Power, Race, Monster) (2022), 1 descendant of its own
- K192618: e-Motion M25 (2020), 1 descendant of its own
- K250748: Klaxon (Twist); Klaxon (Twist R) (2025), 0 descendants of its own

## Recalls of this device
- Aug 12, 2025 · Class I · Z-2538-2025: 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: 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: 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: 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 injur
- Dec 20, 2024 · Class I · Z-1116-2025: 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 injur
- May 10, 2023 · Class II · Z-2004-2023: 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 
- May 10, 2023 · Class II · Z-2005-2023: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K151199
Methodology: https://510kreport.com/methodology