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510(k) Data Aggregation

    K Number
    K223797
    Device Name
    Neuro20 Pro System
    Manufacturer
    Neuro20 Technologies
    Date Cleared
    2023-02-23

    (66 days)

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

    Neuro20 Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance. Other indications for use include: - · Re-educating muscles - · Increasing local blood circulation - · Maintaining or increasing range of motion - · Relaxation of muscle spasm - · Retarding or preventing disuse atrophy
    Device Description
    The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The Neuro20 PRO System is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. The system utilizes electrical stimulation to create an involuntary contractions of motor neurons are transmitted to the muscle fibers where they stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise. Individual intensity levels can be modulated for each muscle group. One to ten patients may be treated within a session. The Neuro20 PRO System is comprised of three major components: the Control Box with battery (the muscle stimulator), Smart Suit (the wearable suit with electrodes covering the muscles), and Operating Tablet with software which allows the medical professional to adjust the parameters for the patient. Users may be actively engaged within a variety of training modes while the clinician/operator controls the software. The Neuro20 PRO System accessories are a battery charger, protective case, and Smart Suit packaging. The Neuro20 Control Box connects to the suit and is powered by a battery. It is controlled by the medical practitioner operating the software. The Smart Suit applies the electrodes to the upper body, arms, legs, and buttocks. The Control Unit is connected to the Operating Tablet wirelessly.
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