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510(k) Data Aggregation

    K Number
    K181955
    Device Name
    WiEMSpro
    Manufacturer
    Medical Cables, S.L.
    Date Cleared
    2019-02-12

    (204 days)

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

    Medical Cables, S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding 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. WIEMSPRO electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, 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. WIEMSero is a device 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. The device must be used over user's cotton undergarments and is therefore not patient-contacting WIEMSPRO system cannot be used while the user is in motion or lifting weights.
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