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510(k) Data Aggregation

    K Number
    K061721
    Device Name
    PEDI-SPIDER STRAP
    Manufacturer
    EMERGENCY PRODUCTS AND RESEARCH
    Date Cleared
    2006-08-17

    (59 days)

    Product Code
    NZD
    Regulation Number
    880.6900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board, by the use of a checker board series of straps that are placed over the patient and secure to the back board with Velcro hook and loop closures on each side of the back board. The device should be used on children from 10 to 100 pounds and 12 to 55 inches in height.
    Device Description
    The Pedi-Spider utilizes 1 ½" nylon or polypropylene material in a cargo net fashion with Velcro on the ends for securing the strap to the backboard.
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    K Number
    K051278
    Device Name
    GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
    Manufacturer
    RG ENT., INC.
    Date Cleared
    2006-06-29

    (408 days)

    Product Code
    DWJ
    Regulation Number
    870.5900
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Geratherm SOS-Vacutherm is a temperature-controlled electric whole body warming system intended for use in preventing or treating the effects of incidental hypothermia in adults while at the rescue scene or during transport by air or ground to a medical facility
    Device Description
    The Geratherm SOS-Vacutherm System is a combination product made of two primary components: 1. An electrically warmed panel. - Class II 2. A integrated vacuum mattress / stretcher - Class I (exempt from 510(k) premarket notification).
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    K Number
    K030283
    Device Name
    BABY POD
    Manufacturer
    PRISM ENTERPRISES, INC.
    Date Cleared
    2003-04-22

    (85 days)

    Product Code
    FPP
    Regulation Number
    880.6900
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    Matched: '880.6900'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Baby Pod is intended to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility.
    Device Description
    Baby Pod is designed to convey a baby to or from a medical facility, between facilities or between departments within a single medical facility. Baby Pod consists of a lightweight carbon fiber outer shell, which is lined with a shock absorbent foam inner layer, and has transparent shields for viewing the baby. Baby Pod contains a patient positioning vacuum mattress, stretcher fixing straps to secure the device for transport, and safety straps to secure the baby inside the device during transport.
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