BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800

    K Number: K112074 · Decision Feb 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    70
    Applicant Total
    29
    Review Days
    196

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    Basic Information

    Device Name
    EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
    K Number
    K112074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Everyway Medical Instruments Co.,Ltd
    Date Received
    July 20, 2011
    Decision Date
    February 1, 2012
    Product Code
    ITH
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITH Equipment, Traction, Powered

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