MT
10 Appendices
10.1 Intended Use and Regulatory Statement
Intended Use
The DX System is a family of components intended to control powered wheelchairs.
The DX System offers flexibility in integrating compatible input and output devices and
provides extensive adaptability to meet specific user needs through optimal
programmability.
The DX System is intended to operate powered wheelchairs utilising 24V motors with
integrated parkbrakes.
Device Classification
Europe
The DX System is a component of a Class I medical device as detailed in the
Council Directive 93/42/EEC concerning Medical Devices.
USA
The DX System 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 System and its components are
designed to comply with the requirements of the European Medical Device Directive
93/42/EEC and 21 CFR § 820.30.
The DX System and its components have been designed such that the combination of the
wheelchair and the DX System, 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.
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