AirPhysio - Mechanical positive pressure airway secretion-clearing device

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by AirPhysio Pty Ltd

I, Elizabeth Butt, as a delegate of the Secretary to the Department of Health, on receipt of an application from AirPhysio Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representation described in paragraph (A), for use in advertising the product identified in paragraph (B) to consumers.

1.  

   • The AirPhysio device is designed to help remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient with respiratory conditions (the Representation).

   The Representation will always be accompanied by the following statement, prominently displayed or communicated adjacent or in close proximity to the Representation, whenever the Representation is used in an advertisement:

   • If you suffer from a respiratory condition, we recommend discussing the suitability of the device with your healthcare professional (the Advisory Statement).
2.  
   • AirPhysio Pty Ltd - Mechanical positive pressure airway secretion-clearing device (ARTG 376021)

Dated this 10th day of February 2022

Signed electronically

Elizabeth Butt
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch