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510(k) Data Aggregation

    K Number
    K191689
    Device Name
    EleGARD Patient Positioning System
    Date Cleared
    2020-02-13

    (233 days)

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

    Minnesota Resuscitation Solutions, d.b.d AdvancedCPR Solutio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EleGARD™ Patient Positioning System is 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 Systems; and patient transport.
    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. It may be used with the patient lying flat or may elevate the patient's thorax and head. The device would be used in emergency conditions when healthcare professionals need to: provide airway management, perform CPR with manual / hand compressions, adjunctive manual CPR devices, and a LUCAS mechanical compression device, perform manual bag / mask ventilation, and transport a patient.
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