High Tech Health - Biofeedback system ('Resperate')

Published in the Commonwealth of Australia Gazette No. GN 21, 31 May 2006

Note: Approval withdrawn 26 June 2007

THERAPEUTIC GOODS ACT 1989

I, RITA MACLACHLAN, Director - Office of Devices, Blood and Tissues, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of Section 42DF(1) of the Therapeutic Goods Act 1989, give notice that the restricted representations described in paragraph (1) below, have been approved for use in advertisements directed to consumers, for the product listed in paragraph (2) provided the conditions identified in paragraph (3) are met:

1. Representations to the effect that advertisements to consumers for the goods described in paragraph 

   1. may refer to:

      "As a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure together with other pharmacological and/or non-pharmacological interventions";

2. High Tech Health Pty Ltd - Biofeedback System ("Resperate") (ARTG Number 116226);
   sponsored by High Tech Health Pty Ltd;
3. Subject to the conditions -
   1. that all current and future advertisements (including Internet websites),
      1. are amended to remove unqualified and / or primary treatment claims such as Resperate "lowers blood pressure", "Resperate has been clinically proven to lower blood pressure", etc;
      2. are amended to remove claims that the product is 'safe or has no side effects';
      3. 'are amended to remove claims that the product is 'cleared by the FDA and TGA' and / or any other government or government agency within 30 days of the date of this notice;
   2. that all future advertisements (including Internet websites) prominently represent the product to be a 'relaxation treatment to relieve stress through guided and monitored breathing exercises which in turn allows the product to be used only as an adjunctive treatment for high blood pressure together with other pharmacological and/or non-pharmacological interventions'; and
   3. that all future advertisements (including each page of Internet websites featuring the product) include the following cautionary statements, prominently displayed
      1. "a medical practitioner is the only person qualified to diagnose high blood pressure and evaluate the meanings of recorded blood pressure"; and
      2. "a medical practitioner should regularly check and monitor high blood pressure".

Dated this 18th day of May 2006

RITA MACLACHLAN
Delegate of the Secretary to the Department of Health and Ageing