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510(k) Data Aggregation

    K Number
    K181219
    Device Name
    OptiPillows EPAP Mask
    Manufacturer
    Cpapnea Medical Supply
    Date Cleared
    2018-08-03

    (88 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cpapnea Medical Supply

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OptiPillows EPAP Mask is intended for use during sleep to alleviate snoring. It is intended for the adult population with snoring only.
    Device Description
    OptiPillows EPAP mask is a nasal dilator device for alleviation of snoring. The EPAP mask is a reusable device. The EPAP mask has nasal pillows that fit against the nostrils similar to the ones used in several nasal pillow CPAP masks. The EPAP mask has a one-way valve attached to it that allows air to flow freely without resistance during inspiration. The mask is held in place with adjustable head straps connected to the sides of the mask. During expiration, the air is redirected through a narrow opening, on the side of the expiratory opening creates resistance to airflow, thus increasing the back pressure in the nose, mouth, and upper airways. The increase in back pressure during expiration prevents the collapse of the upper airways, alleviating airway obstruction. The level of back pressure can be adjusted to the patient comfort by turning a rotating sleeve/collar to open or close the expiratory opening on the side of the valve. The adjustable expiratory resistance improves the comfort and safety for the user and facilitates adaptation to the EPAP mask. The EPAP mask is a small device and is used like a CPAP mask, but does not require using a power supply, a CPAP machine or tubing that restricts movement of the patient during sleep.
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