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

    SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC

    K Number: K051256 · Decision Jul 21, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
    K Number
    K051256
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3420
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Noble Fiber Technologies, Inc.
    Date Received
    May 16, 2005
    Decision Date
    July 21, 2005
    Product Code
    ISH
    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
    ISH Component, External, Limb, Ankle/Foot

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