The Guardian - Alarm, epilepsy

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

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

Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included Class 1


Epilepsy Edge Australia Pty Ltd

Postal Address

13 Glenorchy Road,Southern River, WA, 6110


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




iTs Designs Ltd (Alert-iT Care Alarms)

Fernie House Unit 3 Jackson Street

Coalville Business Park, Leicester, LE67 3NR

United Kingdom


1. The Guardian - Alarm, epilepsy

Product Type

Medical device system

Effective date



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


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

Public Summary

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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.

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