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510(k) Data Aggregation
K Number
K091557Device Name
LUNG FLUTE THERAPEUTIC
Manufacturer
MEDICAL ACOUSTICS
Date Cleared
2010-01-04
(222 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ACOUSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lung Flute® Therapeutic is indicated for Positive Expiratory Pressure (PEP) Therapy.
Device Description
The Lung Flute® Therapeutic is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The Lung Flute® Therapeutic facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
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K Number
K060439Device Name
LUNG FLUTE
Manufacturer
MEDICAL ACOUSTICS LLC
Date Cleared
2006-06-22
(121 days)
Product Code
BYI
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ACOUSTICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LUNG FLUTE™ is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.
Device Description
The LUNG FLUTE™ is shaped like a pipe or flute with a plastic mouthpiece at one end. A Mylar reed is attached inside a square hardened plastic tube that flairs on the end to increase the internal air mass, which provides acoustical impedance. When the patient exhales through the "flute-like" device, the reed inside the tube oscillates and acts in tandem with the rest of the device and the lung cavity itself to produce a sound frequency that approximates the resonance frequency of pulmonary secretions. The LUNG FLUTE™ facilitates mucus clearing by generating and delivering a specific low frequency sound that vibrates the airways and lung secretions, causing lung secretions to thin and become expelled.
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