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

    LAYDOWN ARM SUPPORT MECHANISM

    K Number: K885104 · Decision Dec 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    63
    Applicant Total
    10
    Review Days
    15

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    Basic Information

    Device Name
    LAYDOWN ARM SUPPORT MECHANISM
    K Number
    K885104
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3920
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Rolcontrol Products, Co., Inc.
    Date Received
    December 12, 1988
    Decision Date
    December 27, 1988
    Product Code
    KNN
    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
    KNN Components, Wheelchair

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    Other Clearances by Rolcontrol Products, Co., Inc.

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    K883674 MANUAL SWING ARM