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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?
    Product Code :

    LWF

    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
    Why did this record match?
    Product Code :

    LWF

    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
    Why did this record match?
    Product Code :

    LWF

    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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    K Number
    K982929
    Device Name
    MAXAIR NASAL DILATOR SYSTEM
    Manufacturer
    HNL TECHNOLOGIES
    Date Cleared
    1998-09-09

    (20 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Product Code :

    LWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing. The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.
    Device Description
    The MaxAir™ Nasal Dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing.
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    K Number
    K963326
    Device Name
    BREATHE FIT
    Manufacturer
    CAMBRIDGE ASSOC.
    Date Cleared
    1997-02-12

    (173 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Product Code :

    LWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K962400
    Device Name
    AIR MAX EXTERNAL NASAL DILATOR STRIP
    Manufacturer
    AMERICAN WHITE CROSS, INC.
    Date Cleared
    1996-09-09

    (80 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Product Code :

    LWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962698
    Device Name
    ACUTEK'S CLEARPASAGE
    Manufacturer
    ACUTEK ADHESIVE SPECIALTIES, INC.
    Date Cleared
    1996-09-09

    (84 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Product Code :

    LWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955711
    Device Name
    BREATHE RIGHT NASAL STRIP
    Manufacturer
    CNS, INC.
    Date Cleared
    1996-05-30

    (164 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Product Code :

    LWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954914
    Device Name
    BREATHE RIGHT NASAL STRIP
    Manufacturer
    CNS, INC.
    Date Cleared
    1996-02-27

    (124 days)

    Product Code
    LWF
    Regulation Number
    874.3900
    Why did this record match?
    Product Code :

    LWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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