Side Sleeper Pty Ltd - Freestanding patient positioner, reusable (ARTG 529510)

Therapeutic Goods Act 1989

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

I, Rowena Love, as a delegate of the Secretary to the Department of Health, Disability and Ageing, on receipt of an application from Side Sleeper Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989, the restricted representation described in paragraph (A), for use in advertisements for the product identified in paragraph (B), when the statement identified in paragraph (C) is prominently displayed or communicated in advertisements in which the restricted representation described in paragraph (A) is used.

(A)

A representation to the effect that the ‘freestanding patient positioner’ is designed to reduce snoring and support positional therapy for apnoea.

(B)

Freestanding patient positioner, reusable (ARTG 529510).

(C)

WARNING: Positional therapy may not be suitable for everyone. Alternative treatments may be required. Snoring may not indicate apnoea. Seek medical advice.

Dated this 7^th day of October 26

Signed electronically

Rowena Love 
Delegate of the Secretary to the Department of Health, Disability and Ageing
Regulatory Compliance Branch

1. ^{^}

   prominently displayed or communicated, in relation to a statement in an advertisement, means:
    (a) either:

   1. for a visual statement—easily read from a reasonable viewing distance for the particular media type in the context in which the advertisement is intended to be viewed; or
      (ii)   for a spoken statement—able to be clearly heard and understood; and
      (b) repeated as often as necessary to be noticed by a viewer or listener