SmartDrive Wheelchair Power Assist
MAX MOBILITY, LLC
MAX MOBILITY, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008370857 | 3008370857 | MAX MOBILITY, LLC | 1 | N | 2026-01-01 | 300 DUKE DR Lebanon TN US 37090 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 117963 | 1267974114 | K151199 | SmartDrive Wheelchair Power Assist | ITI | 2015-07-30 |
| 117963 | 1531264084 | K113621 | SMARTDRIVE WHEELCHAIR POWER-ASSIST | ITI | 2012-07-06 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ITI | 2 | 2015-07-30 |
PMN#
GUDID#
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 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.
2017-01-16
SmartDrive® - MX2
2016-09-23