Australia - English - Department of Health (Therapeutic Goods Administration)
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
13 Glenorchy Road,Southern River, WA, 6110
ARTG Start Date
Medical Device Class 1
- 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
1. The Guardian - Alarm, epilepsy
Medical device system
36693 Alarm, epilepsy
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
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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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