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510(k) Data Aggregation

    K Number
    DEN200017
    Device Name
    Q-Collar
    Manufacturer
    Q30 Sports Science, LLC
    Date Cleared
    2021-02-26

    (344 days)

    Product Code
    QNX
    Regulation Number
    890.3050
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Q-Collar is a non-invasive device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts.
    Device Description
    The Q-Collar (Figure 1) is a C-shaped collar intended to be worn around the neck during sports activities. The protuberances located at each end of the device are designed to ensure the correct location of pressure on the neck to provide compressive force to the internal jugular vein (IJV). In order to confirm whether the Q-Collar is properly sized and fits the wearer correctly, an ancillary fitting tool, referred to as the Fit Check (Figure 2), is packaged with the Q-Collar. The Q-Collar and Fit Check are packaged with a carry case (Figure 3) for transport and storage.
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