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510(k) Data Aggregation
K Number
K142482Device Name
The Vest Airway Clearance System
Manufacturer
Hill-Rom Services Private Limited
Date Cleared
2015-05-07
(245 days)
Product Code
BYI
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
Hill-Rom Services Private Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vest® Airway Clearance Systems is intended to provide airway clearance therapy when external manipulation of the thorax is the physician's choice or treatment. Indications for this form of therapy are described by the American Association of Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy. 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 the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Vest® Airway Clearance System is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for the purposes of collecting mucus for diagnostic evaluation.
Device Description
The Vest® Airway Clearance System consists of an inflatable garment attached to an Air Pulse Generator that rapidly inflates and deflates the inflatable garment. This causes the chest wall to be gently compressed and released, which creates airflow within the lungs. This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning. This type of Airway Clearance Therapy is referred to as High Frequency Chest Wall Oscillation (HFCWO).
The system consists of an Air Pulse Generator, connecting hose, and multiple styles and sizes of garments. The garments are single patient, multi-use.
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