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510(k) Data Aggregation
K Number
K051383Device Name
THE INCOURAGE SYSTEM
Manufacturer
RESPIRATORY TECHNOLOGIES, INCORPORATED
Date Cleared
2005-06-17
(21 days)
Product Code
BYI
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
RESPIRATORY TECHNOLOGIES, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The inCourage™ System is indicated when external manipulation of the chest is the physician's treatment of choice for increasing the clearance of mucus in patients with pulmonary disorders. The system promotes airway clearance and improves bronchial drainage utilizing High Frequency Chest Wall Oscillation (HFCWO).
Device Description
The inCourage™ System is designed to assist in the loosening & eliminating of mucus from the lungs, utilizing high-frequency chest wall oscillation (HFCWO), when external manipulation of the chest is the physician's treatment of choice to increase the clearance of mucus. The primary components of The inCourage™ System include a blower, a motordriven valve, a power supply, and a control board that are connected to an inflatable iacket through interconnecting hoses. The blower-valve combination creates oscillating air that is delivered to the jacket via the interconnecting hoses. The result is a mythmic inflation and deflation of the jacket against the user's chest creating high-frequency chest wall oscillation, mobilization, and clearance of bronchial secretions.
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