Lung Flute Is FDA Cleared
The Lung Flute has been cleared by the FDA for use by patients in the USA. It is only medical device that has been FDA cleared for both diagnostic and therapeutic use in secretion mobilization.
Diagnostic Use - The FDA has cleared the Lung Flute (FDA 510(k) number K060439) for the collection of diagnostic sputum samples for a wide range of pulmonary issues, ranging from asthma to diseases such as lung cancer and tuberculosis.
Therapeutic Use - The FDA has cleared the Lung Flute (FDA 510(k) number K091557) for use by patients in Positive Expiratory Pressure (PEP) Therapy. The Lung Flute is able to mobilize mucus held on surfaces within the respiratory tract, even causing patients to expel mucus from deep within the lungs.