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

    ACCUTRAC TRACTION UNIT

    K Number: K930691 · Decision Jul 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    69
    Applicant Total
    8
    Review Days
    162

    Basic Information

    Device Name
    ACCUTRAC TRACTION UNIT
    K Number
    K930691
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I-REP, INC.
    Date Received
    February 10, 1993
    Decision Date
    July 22, 1993
    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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