Kan-Breathe Australia - Mechanical positive pressure airway secretion-clearing device

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Kan-Breathe Australia

I, Michael Shum, as a delegate of the Secretary to the Department of Health, on receipt of an application from Kan-Breathe Australia, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representations described in paragraph (A), for use in advertising the products identified in paragraph (B) to consumers.

1. Kan-Breathe device is designed to be used by patients with diagnosed respiratory conditions to help loosen mucus from the throat and airway (the Representation)
   The Representation must always be accompanied by the following statement, prominently displayed or communicated[1] adjacent or in close proximity to the Representation, whenever the Representation is used in an advertisement:
   • If you suffer from a respiratory condition, Kan-Breathe recommends you discuss the suitability of the device with your healthcare professional (the Advisory Statement).
2. Kan-Breathe Australia - Mechanical positive pressure airway secretion-clearing device (ARTG 391310)

Dated this 11th day of November 2022

Signed electronically

Michael Shum
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch