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

    PULSESTAR EXERCISE BIKE

    K Number: K863884 · Decision Oct 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    17

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    Basic Information

    Device Name
    PULSESTAR EXERCISE BIKE
    K Number
    K863884
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Battle Creek Equipment Co.
    Date Received
    October 6, 1986
    Decision Date
    October 23, 1986
    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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