Tricycle - Disability vehicle, cycle, tricycle, foot-propelled

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Dejay Medical & Scientific Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
321804

Public Summary

Summary for ARTG Entry:

321804

Dejay Medical & Scientific Pty Ltd - Tricycle - Disability vehicle, cycle, tricycle, foot-propelled

ARTG entry for

Medical Device Included Class 1

Sponsor

Dejay Medical & Scientific Pty Ltd

Postal Address

9 Anvil Road,Seven Hills, NSW, 2147

Australia

ARTG Start Date

15/08/2019

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

Theraplay Ltd

32 Welbeck Road Darnley Industrial Estate

Glasgow, Scotland, G53 7SD

United Kingdom

Products

1. Tricycle - Disability vehicle, cycle, tricycle, foot-propelled

Product Type

Medical device system

Effective date

15/08/2019

GMDN

31142 Disability vehicle, cycle, tricycle, foot-propelled

Intended purpose

Tricycle with additional supports for people with disabilities

Specific Conditions

© 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 02.11.2019 at 06:54:50 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

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