BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO RELIEF BRIEF

    K Number: K003128 · Decision Aug 12, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    675

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    Basic Information

    Device Name
    MODIFICATION TO RELIEF BRIEF
    K Number
    K003128
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The JM Kohn Co.
    Date Received
    October 6, 2000
    Decision Date
    August 12, 2002
    Product Code
    NJB
    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
    NJB Orthosis, Truncal, For Dysmenorrhea