The Guardian - Alarm, epilepsy
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-11-2019
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Available from:
Epilepsy Edge Australia Pty Ltd
Class:
Class I
Manufactured by:
iTs Designs Ltd (Alert-iT Care Alarms) Fernie House Unit 3 Jackson Street, Coalville Business Park, Leicester, LE67 3NR United K
Therapeutic area:
36693 - Alarm, epilepsy
Therapeutic indications:
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
Authorization status:
A
Authorization date:
2019-09-06
