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

    PARAPODIUM

    K Number: K791565 · Decision Aug 28, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    503
    Registration Numbers
    503
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    13

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    Basic Information

    Device Name
    PARAPODIUM
    K Number
    K791565
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Physico-Medical Systems Corp.
    Date Received
    August 15, 1979
    Decision Date
    August 28, 1979
    Product Code
    IQI
    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
    IQI Orthosis, Limb Brace

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