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

    ANKLE WEIGHTS

    K Number: K823822 · Decision Jan 14, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    107
    Registration Numbers
    107
    Same Product Code
    10
    Applicant Total
    56
    Review Days
    28

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    Basic Information

    Device Name
    ANKLE WEIGHTS
    K Number
    K823822
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5350
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Danek Medical, Inc.
    Date Received
    December 17, 1982
    Decision Date
    January 14, 1983
    Product Code
    IOD
    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
    IOD Components, Exercise

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