GBK60348: Issue 3 71
5.3 Intended Use and Regulatory Statement
Intended Use
The DX2-REM55x is a component of a DX system intended to allow powered
wheelchair users interaction with the DX System. The DX2-REM55x offers flexibility in
integrating compatible input and output devices, as configured and connected, and
provides extensive adaptability to meet specific user needs through optimal
programmability.
The DX system is intended to operate powered wheelchairs utilizing 24V motors with
integrated park brakes.
The powerchair manufacturers are provided with the integration, set-up, operating
environment, test and maintenance information needed to ensure reliable and safe
use of the controller.
Device Classification
Europe
The DX2-REM55x is a component of a Class I medical device as detailed in the
Council Directive 93/42/EEC concerning Medical Devices.
USA
The DX2-REM55x 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 DX2-REM55x is designed to enable
the powerchair manufacturer to comply with the relevant requirements of the
European Medical Device Directive 93/42/EEC and 21 CFR § 820.
The DX2-REM55x has been designed such that the combination of the wheelchair
and the DX Controller, along with accessories as applicable, complies with the
Essential Requirements of the MDD by adopting relevant clauses of harmonised
standards EN12184 and EN12182 and the FDA Consensus standard ISO 7176 for
performance.
However, final compliance of the complete powerchair system with international and
national standards is the responsibility of the powerchair manufacturer or installer.
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