DJO Global - Orthosis

Therapeutic Goods Act 1989

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

I, Leanne McCauley, as a delegate of the Secretary to the Department of Health, on receipt of an application from DJO Global Pty Ltd have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (A) below only for use in consumer advertising of the products identified in paragraph (B):

1.  
   • Donjoy OA bracing range offers relief of unicompartmental osteoarthritis symptoms whilst being worn, which will always be accompanied by a statement, prominently displayed or communicated,^[1] to the effect that "your healthcare professional will determine whether this product is right for you".
   • Representations referring to "Osteoarthritis" and/or "OA" in the context of stating the product names including:
     • OA Adjuster 3
     • Clima Flex OA
     • OA Nano
     • OA Full Force
     • OA Reaction
2. "DJO Global Pty Ltd - ORTHOSIS" (ARTG 314324)

Dated this 11th day of March 2021

Signed electronically

Leanne McCauley
Delegate of the Secretary to the Department of Health
Advertising and Compliance Education and Policy Section
Regulatory Compliance Branch