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

    STATIONARY EXERCISE BICYCLE

    K Number: K834098 · Decision Dec 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    STATIONARY EXERCISE BICYCLE
    K Number
    K834098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Engineering Dynamics Corp.
    Date Received
    November 28, 1983
    Decision Date
    December 27, 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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    Other Clearances by Engineering Dynamics Corp.

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