Compress

Main information

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

Documents

Localization

  • Available in:
  • Compress, hot pack, chemical
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220600
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220600

Medi Heat Packs - Compress, hot pack, chemical

ARTG entry for

Medical Device Included Class 1

Sponsor

Medi Heat Packs

Postal Address

Unit 2 / 33 Albert Avenue,BORONIA, VIC, 3155

Australia

ARTG Start Date

28/02/2014

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

Jin Yang Trading

493-2 Cheonneung- dong

Dongdaemoon-Gu, Seoul, 34563

Korea - Republic of

Products

1. Compress, hot pack, chemical

Product Type

Single Device Product

Effective date

28/02/2014

GMDN

37697 Compress, hot pack, chemical

Intended purpose

A device that is intended to be applied to a body surface to provide heat therapy to that surface and/or

underlying tissue, e.g. the muscle.

Used when heat may assist with the relief of general aches, pains and cramps by increasing blood flow to

an area of the body, to soothe and relax the area.

This device typically consists of a compact envelope made of plastic which is filled with special chemicals

which is reactive when activated and self-generating the heat. This device can be regenerated for reuse.

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 03:38:43 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