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

    ROTAGYM

    K Number: K832940 · Decision Nov 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    ROTAGYM
    K Number
    K832940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    I-Rep, Inc.
    Date Received
    August 29, 1983
    Decision Date
    November 7, 1983
    Product Code
    ISD
    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
    ISD Exerciser, Measuring

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