Bath

Main information

  • Trade name:
  • Bath, hydro-massage therapy
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bath, hydro-massage therapy
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216802
  • Last update:
  • 10-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216802

Arjo Australia Pty Ltd - Bath, hydro-massage therapy

ARTG entry for

Medical Device Included Class 1

Sponsor

Arjo Australia Pty Ltd

Postal Address

PO Box 330,HAMILTON HILL, WA, 6963

Australia

ARTG Start Date

1/11/2013

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

Meditechnik GmbH Bade- und Hilfssysteme

Ernst-Befort-Strasse 4

, Wetzlar, 35578

Germany

Products

1. Bath, hydro-massage therapy

Product Type

Single Device Product

Effective date

1/11/2013

GMDN

14450 Bath, hydro-massage therapy

Intended purpose

A bath equipped with nozzles that generate many water jets that provide a therapeutic massaging effect,

also known as noninvasive hydrotherapy treatment. This can be used as a pain alleviation treatment for,

e.g. rheumatism patients. This device is specifically designed for use in hospitals and institutions only, and

is not applicable to home use

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 04:13:54 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

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

There are no news related to this product.