SmartDrive®
The device consists of a motorized drive unit that interfaces with the wheelchair frame via removable mounting components. User input commands are provided through compatible control…
The device consists of a motorized drive unit that interfaces with the wheelchair frame via removable mounting components. User input commands are provided through compatible control components, including a switch controller and/or Speed Control Dial (Part Numbers MX2 3DCK, MX2 3DC, MX2 3DCMC). The SpeedControl Dial is no longer commercially available. User input and device configuration may also be supported through compatible Smart Wearable applications operating on SmartDrive MX2+ WearOS and SmartDrive MX2+ WatchOS platforms, which interface with the SmartDrive system. The PushTracker mobile application, available on iOS and WearOS platforms, is used to configure device settings and select control input methods.
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (14), Guangdong (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| Chiaphua Components (Jiangxi) Limited | Yichun | Jiangxi | Contract manufacturer | 23 |
| Feishen Group Co., Ltd. | Yongkang | Zhejiang | Contract manufacturer | 22 |
| Guangdong Marshell Electric Vehicle Co., Ltd. | Zhaoqing | Guangdong | Contract manufacturer | 22 |
| Viscount HI-Tech (Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
| Zhejiang Linix Motor Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 4 |
| Jiangsu Bangbang Intelligent Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 2 |
| Jinhua Ruidi Vehicle Industry Co Ltd | Zhejiang | Zhejiang | Contract manufacturer | 2 |
| Suzhou Green Pine Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Zhenjiang Assure Medical Equipment Co Ltd | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 62. All 62 manufacturers in China registered for Wheelchair, Powered
Record
| Listed by | MAX Mobility, LLC, United States |
|---|---|
| FDA product code | ITI |
| Device type | Wheelchair, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3860 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K151199 |
| Record published | 2017-01-16 |
| Record revised | 2026-05-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2017-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MX2+ | In distribution | |
| MX2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merits | Merits Health Products, Inc. | 186 |
| e-motion® | Alber Gmbh | 129 |
| Modular Power Positioning System | Motion Concepts | 112 |
| e-fix® | Alber Gmbh | 56 |
| TRZ-CG Power Positioning System | Motion Concepts | 54 |
| Batec | Batec Mobility SL. | 48 |
| Drive | Drive DeVilbiss Healthcare | 47 |
| Invacare® TDX® Power Wheelchair | Invacare GmbH | 43 |
| Drivemedical | Drive DeVilbiss Healthcare | 34 |
| Heartway Medical Products Co., Ltd. | Heartway Medical Products Co., Ltd. | 20 |
| Scout | Burke, Inc. | 20 |
| Power Wheelchair | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 18 |
Showing 12 of 277. All products under Wheelchair, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151199 | 2015-07-30 |
| K113621 | 2012-07-06 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| MAX Mobility, LLC | 510(k) number | 2025-08-12 | Class I | 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. | 25,389 units |
| MAX Mobility, LLC | 510(k) number | 2025-08-12 | Class I | 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. | 15,834 units |
| MAX Mobility, LLC | 510(k) number | 2025-08-12 | Class I | 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. | 8,413 units |
| MAX Mobility, LLC | 510(k) number | 2024-12-20 | Class I | 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. | unknown |
| MAX Mobility, LLC | 510(k) number | 2024-12-20 | Class I | 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. | unknown |
| MAX Mobility, LLC | 510(k) number | 2023-05-10 | Class II | 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 device | 18,905 units |
| MAX Mobility, LLC | 510(k) number | 2023-05-10 | Class II | 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 device | 6,196 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.