Compression

Main information

  • Trade name:
  • Compression system stocking/sleeve/suit, multi-chamber, reusable
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Compression system stocking/sleeve/suit, multi-chamber, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220604
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220604

Club Warehouse Australia Pty Ltd - Compression system stocking/sleeve/suit, multi-chamber, reusable

ARTG entry for

Medical Device Included Class IIa

Sponsor

Club Warehouse Australia Pty Ltd

Postal Address

PO Box 12,FITZROY, VIC, 3065

Australia

ARTG Start Date

28/02/2014

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

Mego Afek

Kibbutz Afek

ISRAEL, , 30042

Israel

Products

1. Compression system stocking/sleeve/suit, multi-chamber, reusable

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

44768 Compression system stocking/sleeve/suit, multi-chamber, reusable

Intended purpose

The Recovery Pump powered inflatable massager is indicated for the temporary relief of minor aches &

pains and for temporary increase in circulation in the treated areas of people who are in good health. The

Recovery Pump simulates the kneading & stroking of tissues by an inflatable garment

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 03:37:32 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