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510(k) Data Aggregation

    K Number
    K151640
    Device Name
    ELTRAC 471
    Manufacturer
    ENRAF-NONIUS B.V.
    Date Cleared
    2015-10-16

    (120 days)

    Product Code
    ITH, ELT
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENRAF-NONIUS B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: hermiated discs, bulging or protruding intervertebral discs, degenerative disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.
    Device Description
    The Eltrac 471 traction device applies forces to the spine to alleviate pain caused by a variety of pressure on muscular or skeletal structures. It exerts defined forces on the human body to alleviate pain and utilizes computer technology for programming of different kinds of traction. This device is intended for use by professional users only, such as qualified personnel in physiotherapy, rehabilitation and adjacent areas. The device is designed with a plastic housing that holds the motor and has a full color touch screen interface on which the professional user can enter various parameters by touch. The forces from the motor are transferred to the patient by cords and connected accessories. Sequential programming is possible for programming combinations of traction which can be stored as favorites for later use.
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    K Number
    K030297
    Device Name
    FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130
    Manufacturer
    ENRAF-NONIUS B.V.
    Date Cleared
    2003-04-28

    (90 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENRAF-NONIUS B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Electrical Stimulation
    Device Description
    The Flexible Rubber Electrodes are a family of electrodes that are supplied as accessories to Enraf-Nonius B.V. nerve and muscle stimulation equipment. Depending on electrode size and connection terminals, the following parts apply: 1460265 6 x 8 cm electrode with 4 mm female connection terminal, 1460272 4 x 6 cm electrode with 4 mm female connection terminal, 1460274 8 x 12 cm electrode with 4 mm female connection terminal, 3444128 4 x 6 cm electrode with 2 mm female connection terminal, 3444129 6 x 8 cm electrode with 2 mm female connection terminal, 3444130 8 x 12 cm electrode with 2 mm female connection terminal. The electrodes consist of carbon filled silicon rubber. For proper electrical contact with the patient the electrodes should be used in combination with moistened sponge pads. The electrode/sponge assembly is wrapped to the patient using fixation straps. Instructions for use are available in the Operating Instructions of the Enraf-Nonius B.V. nerve and muscle stimulators that the electrodes are to be used with. The following accessories apply: 1460266 Sponges Pads 6 x 8 cm, set of 4 pc, 1460273 Sponges Pads 4 x 6 cm, set 4 pc, 1460275 Sponges Pads 8 x 12 cm, set 4 pc, 3444020 Fixation strap 100 x 3 cm, 3444021 Fixation strap 250 x 3 cm.
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