Cold

Main information

  • Trade name:
  • Cold air therapy unit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cold air therapy unit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222139
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222139

Syneron Candela Corporation Australia Pty Ltd - Cold air therapy unit

ARTG entry for

Medical Device Included Class IIa

Sponsor

Syneron Candela Corporation Australia Pty Ltd

Postal Address

PO Box 252,PROSPECT, SA, 5082

Australia

ARTG Start Date

8/04/2014

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

Zimmer MedizinSysteme GmbH

Junkersstrasse 9

, Neu-Ulm, 89231

Germany

Products

1. Cold air therapy unit

Product Type

Single Device Product

Effective date

8/04/2014

GMDN

36758 Cold air therapy unit

Intended purpose

a source of cold air that is directed at inflamed areas of the body to ease pain

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 10:39:10 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

26-10-2018

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FDA - U.S. Food and Drug Administration

16-3-2015

New management at the DHMA

New management at the DHMA

As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Anne-Marie Vangsted will continue as Director with special responsibility for the DHMA's supervision.

Danish Medicines Agency

There are no news related to this product.