Perineometer

Main information

  • Trade name:
  • Perineometer
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Perineometer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217169
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217169

Analytica Ltd - Perineometer

ARTG entry for

Medical Device Included Class 1

Sponsor

Analytica Ltd

Postal Address

GPO Box 670,BRISBANE, QLD, 4001

Australia

ARTG Start Date

12/11/2013

Product category

Medical Device Class 1

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

Analytica Ltd

320 Adelaide Street

BRISBANE, QLD, 4000

Australia

Products

1. Perineometer

Product Type

Medical device system

Effective date

12/11/2013

GMDN

32686 Perineometer

Intended purpose

The device may be used to assist in the correction of urinary incontinence by means of exercise. It may

also be used by a health care practitioner to assist in the diagnosis and monitoring of urinary incontinence.

The device consists of a rigid probe for temporary intravaginal use which offers resistance to a patient's

voluntary pelvic floor muscle contractions and can provide an indication of the strength of these muscles.

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 03:12:01 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