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510(k) Data Aggregation

    K Number
    K243290
    Device Name
    BTL-785MJ
    Manufacturer
    BTL Industries, Inc.
    Date Cleared
    2025-05-09

    (203 days)

    Product Code
    NUW, NFO
    Regulation Number
    890.5850
    Why did this record match?
    Product Code :

    NUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BTL-785MJ device with the controller and single-use applicators has the following indications for use: 1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain 2. Muscle re-education 3. Increasing blood flow 4. Maintain or increase mandibular range of motion
    Device Description
    The BTL-785MJ is a state-of-the-art electrostimulation and radiofrequency platform with accessories that enables the application of therapy by electrical stimulation. The control unit of the system is equipped with a large color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The generated electromagnetic field is intended to interact with the tissues of the human body in order to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, muscle re-education, increase blood flow and maintain or increase mandibular range of motion. The BTL-785MJ device consists of the following main components: - Main unit - Handpiece - Holding arm - Connection cables - Single-use applicators - Therapy discomfort button
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    K Number
    K203525
    Device Name
    D function
    Manufacturer
    ITO CO., LTD.
    Date Cleared
    2021-05-05

    (155 days)

    Product Code
    NUW
    Regulation Number
    890.5850
    Why did this record match?
    Product Code :

    NUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain 2) Muscle re-education 3) Increasing blood flow 4) Maintain or increase mandibular range of motion
    Device Description
    This device is a current stimulation device with Therapeutic Electro Muscle Stimulator function. Power is supplied by the built-in rechargeable lithium batter. The stimulation current generated by the output circuit of the main body is supplied to the user through the electrode to realize current stimulation. The device is equipped with PAIN mode and MCR mode. Each CH can output independently and be adjusted. If it outputs in CARE mode, it can be used for both outputs at the same time.
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    K Number
    K040400
    Device Name
    MYO-TRODE SG DISPOSABLE ELECTRODE
    Manufacturer
    MYOTRONICS-NOROMED, INC.
    Date Cleared
    2004-07-20

    (154 days)

    Product Code
    NUW
    Regulation Number
    890.5850
    Why did this record match?
    Product Code :

    NUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.
    Device Description
    A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.
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    K Number
    K031998
    Device Name
    MODEL J-5 MVO-MONITOR
    Manufacturer
    MYOTRONICS-NOROMED, INC.
    Date Cleared
    2003-07-24

    (27 days)

    Product Code
    NUW
    Regulation Number
    890.5850
    Why did this record match?
    Product Code :

    NUW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ) dysfunction and associated pain, to relax muscles and establish a physiologic occlusion, to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.
    Device Description
    The device is an ultra-low frequency, battery operated muscle stimulator used to relax the muscles of the head and neck. It is capable of stimulating either two or four muscle groups at once.
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