Due to the definition of Active Medical device for therapy, as per below, our indicative advice would be that the device would fall under the classification of a Class IIa or Class IIb. This is due to claims presented by the manufacturer.

Active medical device for therapy means an active medical device that is intended by the manufacturer to be used on a human being, either alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or alleviating an illness, injury or handicap.

It is the responsibility of the manufacturer to classify the device. However, the classification rules can be found in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regs). Specifically the below information, taken from the Regs, could likely relate to the product.

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