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

    ACCUTRED SHOE

    K Number: K991313 · Decision Jun 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    68

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    Basic Information

    Device Name
    ACCUTRED SHOE
    K Number
    K991313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5575
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orthopedic Technology Research, Inc.
    Date Received
    April 16, 1999
    Decision Date
    June 23, 1999
    Product Code
    IRN
    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
    IRN Device, Warning, Overload, External Limb, Powered

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