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510(k) Data Aggregation

    K Number
    K221901
    Device Name
    EleGARD
    Date Cleared
    2022-07-29

    (29 days)

    Product Code
    Regulation Number
    880.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    AdvancedCPR Solutions LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EleGARD™ Patient Positioning System (EleGARD) is a cardiopulmonary board which may elevate a patient's head and thorax: including during airway management; during manual CPR, manual CPR adjuncts, CPR with the LUCAS® Chest Compression System or ARM XR Automated Chest Compressor; and patient transport. EleGARD is indicated for adults only when used with the LUCAS Chest Compression System or the ARM XR Automated Chest Compressor. When not used with an automated compression system, EleGARD can be used for adults and children, not including infants and neonates.
    Device Description
    The EleGARD™ patient positioning system is an electrically powered device on which a patient is placed. It can be used to elevate a patient's head and thorax during a number of different procedures, e.g., airway management and different CPR techniques. The EleGARD™ acts as a back board for airway management and for performing CPR. It allows the user to position the patient in supine or with the head and thorax elevated. The EleGARD™ is a cardiopulmonary back board which is placed under the patient. There are several different CPR methods which use a back board, stretcher or bed, e.g., manual CPR, manual CPR Adjuncts, and with the Defibtech Chest Compression System and ARM XR backplate or with the LUCAS Chest Compression System as previously cleared under K191689.
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