Summary for ARTG Entry:
Novis Healthcare Pty Ltd - Pressure alleviation pad, <specify>
ARTG entry for
Medical Device Included Class 1
Novis Healthcare Pty Ltd
PO Box 788,LANE COVE, NSW, 1595
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.
Span America Medical Systems Inc
70 Commerce Avenue
GREENVILLE, SC, 29606
United States Of America
1. Pressure alleviation pad, <specify>
Single Device Product
35225 Pressure alleviation pad, <specify>
A device designed to prevent pressure sores, e.g. bed sores or decubitus ulcers, occurring on the parts of
the patient's body which are prone to this. It can equally be used as an underlay for the patient when
he/she is undergoing a long treatment where the body is immobilised, or for disabled, infirm persons who
are confined to lying positions. It is shaped as a mattress, filled with air and is intended to distribute an
equal pressure between the patient and bed over a larger surface area so there is less pressure on the
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:56:31 AEDT
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