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

    POWER EXERCISE EQUIPMENT

    K Number: K874196 · Decision Dec 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    POWER EXERCISE EQUIPMENT
    K Number
    K874196
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Arc Motion , Ltd.
    Date Received
    October 14, 1987
    Decision Date
    December 10, 1987
    Product Code
    BXB
    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
    BXB Exerciser, Powered

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