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510(k) Data Aggregation

    K Number
    K071431
    Device Name
    GLOBUS GENESY 1100 STIMULATOR
    Manufacturer
    DOMINO S.R.L.
    Date Cleared
    2007-09-21

    (121 days)

    Product Code
    IPF, GZJ, LIH
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOMINO S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms: - Management of chronic, intractable pain - Post-traumatic acute pain - Post-surgical acute pain
    Device Description
    The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator. Each device in the family comes with a menu to select different stimulation The Stimulation Programs have been subdivided in menus and programs. submenus to facilitate use for various types of uses. The user can create and store protocols in the device for subsequent recall, and can store them and manipulate them in a PC for labeling and stimulation parameter changes. The Globus Genesy electrical impulses trigger excitations that are transmitted to the muscle fibers, where they generate mechanical responses that result in muscle work. This work is used for muscle and range-of-motion rehabilitation therapies. They also interact with the mechanism of pain generation and transmission in the nerve fibers; other stimulation currents interact directly with the affected body part to obtain the effect desired by the physician or licensed practitioner. The core of the Globus Genesy device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.
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    K Number
    K061632
    Device Name
    GLOBUS PREMIUM MUSCLE STIMULATOR
    Manufacturer
    DOMINO S.R.L.
    Date Cleared
    2007-04-30

    (322 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    DOMINO S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated
    Device Description
    The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in the family comes with a menu to navigate between different stimulation programs. The Stimulation Programs have been subdivided in menus and submenus to facilitate use for various types of uses. The Globus Premium Stimulators electrical impulses trigger action potentials on motor neurons of motor nerves. These excitations are transmitted via the motor end-plate to the muscle fibers, where they generate mechanical responses that result in muscle work. Depending on the electrical impulse parameters (current intensity, frequency, shape of the impulse, duration of contraction, duration of rest, total session duration) different types of muscle work can be performed. This work is able to improve or facilitate muscle performance, and may therefore be considered a muscle training technique. The Globus Premium family models include the Globus Premium Sport and the Globus Premium Fitness. The configurations differ in the navigation menus that allow the user to select the pre-stored electrostimulation programs offered, but offer technically-identical electrostimulations. The core of the Globus Premium device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.
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