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

    EXTENTRAC

    K Number: K980021 · Decision May 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    126

    Basic Information

    Device Name
    EXTENTRAC
    K Number
    K980021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVANCED BACK TECHNOLOGIES
    Date Received
    January 5, 1998
    Decision Date
    May 11, 1998
    Product Code
    JFB
    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
    JFB Table, Physical Therapy, Multi Function

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    Other Clearances by ADVANCED BACK TECHNOLOGIES

    K Number Device Name
    K031996 EXTENTRAC ELITE