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510(k) Data Aggregation

    K Number
    K982178
    Device Name
    VAGABOND SOFT RESTRAINT SYSTEM
    Manufacturer
    EMERGENT INNOVATIONS, LTD.
    Date Cleared
    1999-01-26

    (218 days)

    Product Code
    FMQ
    Regulation Number
    880.6760
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMERGENT INNOVATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Yagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride. Vagabond for EMS Transport: This application is used for adults and pediatric patients when they are picked up in the field by Emergency Medical Service personnel and an EMS board is used for transport. Instead of using single straps the Vagabond provides eight points of secure side release locks along iwth a combination of webbing and netting to safely secure the patient to the baord for transport. Vagabond for Panoose Application: The papose application is necessary for the pediatric patients who require emergency room procedures sucha as suturing or other Minor procedures where they need to remain tionary. The Vagabond board and restrain system comfortabily holds the child in place and can serve as an and for transport whent he child might need to be transferred to another dept. of a hospital. This is accomplished by merely lifting the patient and the board onto a cot or rolling bed. Yagabond for bed restraint: This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the and there is concent by providing a comfortable restraint that serves to keep them in bed.
    Device Description
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