Compress

Main information

  • Trade name:
  • Compress, hot/cold pack, reusable
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Compress, hot/cold pack, reusable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222795
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222795

St Francis Pharmaceuticals - Compress, hot/cold pack, reusable

ARTG entry for

Medical Device Included Class 1

Sponsor

St Francis Pharmaceuticals

Postal Address

10 Blackly Row,COCKBURN CENTRAL, WA, 6164

Australia

ARTG Start Date

24/04/2014

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

Foshan Soft Medical Treatment Health Care

Products Co Ltd

2/F Building 3 No 4 Qinggong 3rd Road

Foshan, Guangdong,

China

Products

1. Compress, hot/cold pack, reusable

Product Type

Single Device Product

Effective date

24/04/2014

GMDN

37240 Compress, hot/cold pack, reusable

Intended purpose

Hot Cold Gel Pack to be heated in microwave, or frozen in freezer. For use for general body pain,

including muscle pain and joint pain. Reusable.

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 07:50:13 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