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

    ISOSTATION LOWER BACK MACHINE

    K Number: K842296 · Decision Jun 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    6
    Review Days
    11

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    Basic Information

    Device Name
    ISOSTATION LOWER BACK MACHINE
    K Number
    K842296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Isotechnologies, Inc.
    Date Received
    June 11, 1984
    Decision Date
    June 22, 1984
    Product Code
    IKK
    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
    IKK System, Isokinetic Testing And Evaluation

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    K854621 ISOSTATION KNEE MACHINE (K-100)
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