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    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
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    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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    K Number
    K120665
    Device Name
    INVENT SNORING DEVICE
    Manufacturer
    VENTUS MEDICAL, INC.
    Date Cleared
    2012-06-12

    (99 days)

    Product Code
    LWF
    Regulation Number
    874.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InVent Snoring Device is intended to reduce or eliminate snoring.
    Device Description
    As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.
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    K Number
    K040491
    Device Name
    CHIN-UP STRIP
    Manufacturer
    DALE MILLER, INC. - THE CHIN-UP COMPANY
    Date Cleared
    2004-09-10

    (197 days)

    Product Code
    LWF
    Regulation Number
    874.3900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chin-Up Strip promotes and enhances nasal breathing to help Breathe Right nasal strips to reduce or eliminate snoring. The Chin-Up Strip supports the chin (mandible) during sleep, thereby promoting and reducing mouth breathing and oral venting.
    Device Description
    Not Found
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