Telemedicine

Main information

  • Trade name:
  • Telemedicine system, video conferencing
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Telemedicine system, video conferencing
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217588
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217588

Device Technologies Australia Pty Ltd - Telemedicine system, video conferencing

ARTG entry for

Medical Device Included Class IIa

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

21/11/2013

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

InTouch Technologies Inc

6330 Hollister Avenue

Goleta, CA, 93117

United States Of America

Products

1. Telemedicine system, video conferencing

Product Type

Medical device system

Effective date

21/11/2013

GMDN

36303 Telemedicine system, video conferencing

Intended purpose

The Remote Presence System (RPS) is a Telemedicine device that provides a means of transmitting,

receiving, and storing real-time audio, video and patient data between physicians and patients, family

members or other healthcare professionals. The RPS incorporates a pre-mounted stethoscope which

allows remote auscultation.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:46:01 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

There are no news related to this product.