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    K Number
    K101859
    Device Name
    REL-K ARTIFICAL LIMB PROSTHESIS
    Manufacturer
    RIZZOLI ORTOPEDICA S.P.A.
    Date Cleared
    2010-10-13

    (103 days)

    Product Code
    ISY
    Regulation Number
    890.3420
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    Product Code :

    ISY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    REL-k is a prosthetic knee, important element of a lower limb prosthesis, a medical device that is used to replace a missing or deformed limb in both static and dynamic deambulation functions
    Device Description
    The Rel-k is an artificial limb prosthesis indicated for individuals that have undergone a trans-femoral amputation. The Rel-k is intended to replace a missing or deformed limb and functions in both normal/standing (static) and dynamic walking. The Rel-k consists of: Pyramidal Head, Angular Sensor, Force sensor, Servo assisted Hydraulic Damper (MPC damper), Removable Battery and electronics compartment, Carbon Fiber Shell (outer casing), Attachment for a standard 30mm diameter tube.
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