The Guardian - Alarm, epilepsy

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

Buy It Now

Available from:
Epilepsy Edge Australia Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
322789

Public Summary

Summary for ARTG Entry:

322789

Epilepsy Edge Australia Pty Ltd - The Guardian - Alarm, epilepsy

ARTG entry for

Medical Device Included Class 1

Sponsor

Epilepsy Edge Australia Pty Ltd

Postal Address

13 Glenorchy Road,Southern River, WA, 6110

Australia

ARTG Start Date

6/09/2019

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

iTs Designs Ltd (Alert-iT Care Alarms)

Fernie House Unit 3 Jackson Street

Coalville Business Park, Leicester, LE67 3NR

United Kingdom

Products

1. The Guardian - Alarm, epilepsy

Product Type

Medical device system

Effective date

6/09/2019

GMDN

36693 Alarm, epilepsy

Intended purpose

The P139 models cover a range of small monitors that detect abnormal conditions occurring in a bed that

might indicate an Epilepsy Episode. These cover bed movement (gross & shallow), bed wetting, sounds

and bed vacation. The alarms are transmitted by Safelink Radio or to a connected Nurse Call or Telecare

system

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 04:52:06 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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