K Care Healthcare Solutions
Assistive Technology Standards List
In light of the requirements to provide NDIS with Australian Standard information when applying for General Assistive Technology (AT) devices, K Care Healthcare Solutions has prepared the following information to assist our dealers, OT’s and other prescribers to complete the application form.
Where required, AT Devices manufactured by K Care Healthcare Solutions are registered with the Therapeutic Goods Administration (TGA) and where applicable, comply with Australian standards as set out in the below table.
Where available, ARTG/TGA registration and relevant standards information for other AT Devices sold by K Care Healthcare Solutions are also set out in the table.
K Care Healthcare Solutions undertakes risk management activities related to all medical devices in accordance with EN ISO 14971.
Regardless of the risk management activities undertaken by K Care Healthcare Solutions and conformity to relevant Australian Standards, purchasers/prescribers are advised to undertake their own risk assessment activities to determine if this product introduces unacceptable risks in their own application and environment.
The below table is current as of 2nd March 2022. The table may be updated from time to time, and all future versions will be published on our website at www.kcare.com.au.
Where required, AT Devices manufactured by K Care Healthcare Solutions are registered with the Therapeutic Goods Administration (TGA) and where applicable, comply with Australian standards as set out in the below table.
Where available, ARTG/TGA registration and relevant standards information for other AT Devices sold by K Care Healthcare Solutions are also set out in the table.
K Care Healthcare Solutions undertakes risk management activities related to all medical devices in accordance with EN ISO 14971.
Regardless of the risk management activities undertaken by K Care Healthcare Solutions and conformity to relevant Australian Standards, purchasers/prescribers are advised to undertake their own risk assessment activities to determine if this product introduces unacceptable risks in their own application and environment.
The below table is current as of 2nd March 2022. The table may be updated from time to time, and all future versions will be published on our website at www.kcare.com.au.
