(450 days)
The Lung Trainer device is intended to be used as (1) an expiratory breathing exerciser for respiratory muscles, and (2) to be used as an expiratory resistance device, providing positive expiratory pressure (PEP) to substitute for pursed lip breathing and to assist in mucus clearance. The LungTrainer device is intended for use in patients ages 12 years and up in a clinical or home use environment.
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I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the "LungTrainer (MD2 & MD3)" device, outlining its regulation, product code, and indications for use. It primarily addresses administrative and regulatory compliance aspects rather than technical performance studies or acceptance criteria. Therefore, I cannot extract the requested information from this document.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).