(64 days)
The PARI PEP Device is an Expiratory Resistance Exerciser and ii was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home. doctor's office, hospitals and clinics.
The PARI PEP Device is an Expiratory Resistance Exerciser. The PARI PEP was designed to work with the PARI Nebulizers.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance metrics, or details of a study with a test set, training set, or expert involvement to establish ground truth. The document is an FDA letter regarding the substantial equivalence of the PARI PEP® Positive Expiratory Pressure Therapy System, which primarily discusses regulatory classification and marketing authorization. It does not include a technical or clinical study summary.
§ 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).