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510(k) Data Aggregation

    K Number
    K212413
    Device Name
    I-Motion
    Date Cleared
    2022-05-26

    (296 days)

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

    I-Motion Group Global Iberica S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    I-MOTION intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The I-MOTION is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contra indicated. I-MOTION is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes. I-MOTION electrical impulses allow the triggering o faction potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor end plate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
    Device Description
    The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances. None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. I-MOTION is a device for electronic muscle stimulation based on EMS technology. As for its use, the device is specifically designed as a complement to other sports and to train muscles. It must be used only for healthy muscles and clients, not for rehabilitation purposes. The device must be worn over the user's cotton underwear, the electrodes do not come into direct contact with the client. The I-MOTION System cannot be used while the user is moving or lifting weights.
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