Exerciser

Main information

  • Trade name:
  • Exerciser, continuous passive motion,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Exerciser, continuous passive motion,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220558
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220558

TV Innovations Pty Ltd - Exerciser, continuous passive motion, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

TV Innovations Pty Ltd

Postal Address

7 / 17 Stanton Road,Seven Hills, NSW, 2147

Australia

ARTG Start Date

27/02/2014

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

TV Products HK Ltd

Unit 2708 Greenfield Towers No 1 Science

Museum Road

Tsim Sha Tsui, Kowloon,

Hong Kong - SAR of China

Products

1. Exerciser, continuous passive motion, <specify>

Product Type

Single Device Product

Effective date

27/02/2014

GMDN

11631 Exerciser, continuous passive motion, <specify>

Intended purpose

An electrically powered device that moves legs alternately by continuous passive motion without muscular

exertion from the patient. This treatment helps reduce back and leg pain; oedema; or stiffness in muscles

and joints. It stimulates blood circulation and produces a sensation of comfort without impact to ankle and

knee joints.

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 03:44:57 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