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510(k) Data Aggregation

    K Number
    K201581
    Device Name
    CPR BAND
    Manufacturer
    CREDO
    Date Cleared
    2021-03-06

    (268 days)

    Product Code
    LIX
    Regulation Number
    870.5210
    Why did this record match?
    Applicant Name (Manufacturer) :

    CREDO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CPR BAND is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
    Device Description
    The CPR BAND is a small, lightweight device that uses rechargeable batteries and is worn on the wrist. This device is designed for first aid personnel trained in CPR and use of the CPR BAND. The CPR BAND (Model: CREDO-CB) provides real-time information about chest compression according to the latest CPR guideline when CPR is performed on patient who is estimated a sudden cardiac arrest (SCA). This device displays CPR feedback indicator for the chest compression depth. It guides chest compression rhythm through sound and indicates the total chest compression time and number of chest compression. The CPR BAND is a device that provides Bluetooth function. It can transmit CPR record and confirm information on the mobile application of the smart device in order to training CPR Skill for user via checking data. In the smart device that provides the wireless communication function by receiving information provided by the CPR BAND, it can display the pressure axis angle, pressure axis average value, compression depth average value, compression rhythm average value, and chest compression graph which are not displayed on the CPR BAND. The device provides other functions on the user's wrist while waiting without CPR. The time, step count, movement distance and calorie consumption function are displayed.
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