6.2
Intended Use and Regulatory Statement
Intended Use
The DX-GB is a component of the DX System intended to provide speed and direction
control of dual, compatible 24V brushless motors and release of normally-activated park
brakes located on a powerchair.
The DX-GB receives input commands from a DX Master Remote.
The wheelchair manufacturers are provided with all the integration, set-up, operating
environment, test and maintenance information needed in order to ensure reliable and safe
use of the controller.
Device Classification
Europe
The DX-GB Controller is a component of a Class I medical device as detailed in the
Council Directive 93/42/EEC concerning Medical Devices.
USA
The DX-GB Controller is a component of a Class II medical device (Powered
Wheelchair) as detailed in 21 CFR § 890.3860.
Compliance and Conformance with Standards
In accordance with the device classification, the DX-GB wheelchair controller is designed to
comply with the requirements of the European Medical Device Directive 93/42/EEC and US
21 CFR § 820.30.
The DX-GB Controller has been designed such that the combination of the wheelchair and
the DX-GB Controller, along with accessories as applicable, complies with the requirements
of the MDD Harmonised standards EN12184 and EN12182 and the FDA Consensus standard
ISO 7176 for performance.
However, final compliance of the complete wheelchair system with international and
national standards is the responsibility of the wheelchair manufacturer or installer.
GBK64048
: Issue 1 – June 2007
44
