Stimulator

Main information

  • Trade name:
  • Stimulator, caloric, vestibular function
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stimulator, caloric, vestibular function
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222645
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222645

Interacoustics Pty Ltd - Stimulator, caloric, vestibular function

ARTG entry for

Medical Device Included Class IIa

Sponsor

Interacoustics Pty Ltd

Postal Address

PO Box 238,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/04/2014

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

Interacoustics AS

Drejervaenget 8

Assens, , 5610

Denmark

Products

1. Stimulator, caloric, vestibular function

Product Type

Single Device Product

Effective date

17/04/2014

GMDN

34891 Stimulator, caloric, vestibular function

Intended purpose

A stimulator that applies heat stimuli in the form of a stream of air or water into the ear canal. Vestibular

function stimulators consist of an irrigation system that include a pump, valves, heaters, regulators to

control the rate of flow and temperature of the medium. The stimulation of the semicircular canal produces

involuntary eye movements which are measured using a nystagmograph. It is used for vestibular function

testing for assessing the patient's balance system.

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 09.11.2017 at 08:42:04 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