Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Ascencia Pty Ltd - Chest-oscillation airway secretion-clearing system
ARTG entry for
Medical Device Included Class IIa
Ascencia Pty Ltd
28 Waverley Park Drive,MULGRAVE, VIC, 3170
ARTG Start Date
Medical Device Class IIa
- 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.
611 Chemin de l'Ardrech
, Seillans, 83440
1. Chest-oscillation airway secretion-clearing system
Medical device system
38124 Chest-oscillation airway secretion-clearing system
The RespIn 11 is intended to provide bronchial clearance therapy when external manipulation of the
thorax is the physician's choice of treatment. Indications for this form of therapy are described by the
American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural
Drainage Therapy' (1991). According to AARC guidelines, specific indications for external manipulation of
the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having
difficulty with secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the
RespIn 11 is also indicated for external manipulation of the thorax to promote bronchial clearance or
improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation
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Produced at 02.11.2019 at 06:20:43 AEDT
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