Search Results

Respiratory Muscle Trainer is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. Respiratory Muscle Trainer vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.

The device may also be useful in the removal of mucus from patients who have chronic bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

Not Found

This document is a 510(k) clearance letter for a "Respiratory Muscle Trainer." It does not contain the information requested about acceptance criteria or a study proving device performance.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements and general controls. It also includes the "Indications for Use" for the device, but this is distinct from performance criteria and study results.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device