Chest-oscillation airway secretion-clearing system

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

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Ascencia Pty Ltd
Class IIa
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


Ascencia Pty Ltd - Chest-oscillation airway secretion-clearing system

ARTG entry for

Medical Device Included Class IIa


Ascencia Pty Ltd

Postal Address

28 Waverley Park Drive,MULGRAVE, VIC, 3170


ARTG Start Date


Product category

Medical Device Class IIa



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.




Respinnovation SAS

611 Chemin de l'Ardrech

, Seillans, 83440



1. Chest-oscillation airway secretion-clearing system

Product Type

Medical device system

Effective date



38124 Chest-oscillation airway secretion-clearing system

Intended purpose

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

Specific Conditions

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Public Summary

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Produced at 02.11.2019 at 06:20:43 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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