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510(k) Data Aggregation

    K Number
    K230532
    Device Name
    RADx Intraoral Appliance for Snoring and Sleep Apnea
    Manufacturer
    Date Cleared
    2023-07-12

    (135 days)

    Product Code
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Achaemenid LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
    Device Description
    The RADx White Night and RADx White Night-p Intraoral Appliance for Snoring and Mild to Moderate Sleep Apnea are removable intraoral devices used for treating snoring and mild to moderate obstructive sleep apnea. It consists of two custom fabricated adjustable rods that fit separately over the upper and lower teeth. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The device is a prescription device customized for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The device can be adjusted only by the user and / or the dentist in increments of 0.5 mm. The custom oral appliance is checked for proper and comfortable fit as well as the appropriate initial progressive arm attachment. The dentist will provide the patient with subsequent progressive arms from 1.0 mm up to 5.0mm in 0.5mm increments. There are 9 different arms each identified with a number for each side of the jaw. The arms are also identified as either "L" for left or "R" for right. Variants / Configurations There are two variants of the device. The RADx White Night has removable progressive arms with the female housing active as the receptacle for the arms. The RADx White Night-p was designed with the upper housing and arm as one piece. In this version, the fixed upper tray-arm combination are the progressive parts of the entire apparatus.
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    K Number
    K112126
    Device Name
    GENUINE FIRST AID CPR MASK
    Date Cleared
    2011-12-01

    (129 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENUINE FIRST AID LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
    Device Description
    Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
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    K Number
    K102299
    Device Name
    CPR FACE MASK
    Date Cleared
    2011-03-18

    (217 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENUINE FIRST AID LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
    Device Description
    Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use. CPR mask includes: One-way filter valve PVC mask with oxygen port Elastic Strap Packaged for easy portability and quick access
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    K Number
    K041517
    Device Name
    INFUSIONCATH
    Manufacturer
    Date Cleared
    2004-08-05

    (59 days)

    Product Code
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    ID LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
    Device Description
    The VeinRx InfusionCath is used to temporarily occlude a vessel in the peripheral vasculature and then deliver a predetermined dose of a physician specified fluid proximally along the inner lumen of the vessel. The VeinRx InfusionCath is comprised of a distal occlusion balloon, a variable treatment length catheter body with elution holes, and a proximal trifurcated Luer connection hub. The Trifurcated hub allows connections for to the following three main systems of the device. The Luer Lock connections for balloon inflation, infusion valve operation and fluid infusion. The device is provided sterile and for single patient use.
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