Actegy - Revitive

Therapeutic Goods Act 1989

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

I, Pio Cesarin, Assistant Secretary, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Actegy Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b):

1. Representations, used alone or in any combination, to the effect that Revitive may:
   • reduce swelling in the knee caused by osteoarthritis
   • reduce pain and discomfort associated with knee osteoarthritis
   • reduce pain and discomfort in the legs caused by diabetic peripheral neuropathy
   • increase muscle strength in the legs of people with knee osteoarthritis
   • increase muscle strength in the legs of people affected by COPD
2. in conjunction with the following advisory statements and contraindications displayed in accordance with the requirements set out in section 6(3)(d) of the Therapeutic Goods Advertising Code^[1]:

• Warning: Consult with your health care professional before use.
• Do not use if: 
  • fitted with an electronic implanted device such as a heart pacemaker or Automatic Implantable Cardioverter Defibrillator (AICD);
  • you are pregnant;
  • being treated for , or have symptoms of Deep Vein Thrombosis (DVT): such as pain, swelling and tenderness, heavy ache, warm or red skin in the leg.

2. "Revitive" (stimulator, electrical, analgesic, peripheral nerve, transcutaneous - ARTG No. 206176)

Dated this 3rd day of November 2016

Pio Cesarin
Delegate of the Secretary to the Department of Health; and
Assistant Secretary
Regulatory Practice, Education and Compliance Branch