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510(k) Data Aggregation

    K Number
    K242926
    Device Name
    XBody Go USA, XBody Pro USA
    Manufacturer
    XBody Hungary Kft.
    Date Cleared
    2025-05-30

    (248 days)

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

    XBody Hungary Kft.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XBODY Go USA and XBODY Pro USA are machines with electronic muscle stimulation based on EMS technology. The devices are specifically designed as an addition to other sports and for training muscles. They must be used only for healthy muscles and clients, not for rehabilitation purposes. Both models are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. Neither model is intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA or XBODY Pro USA training programs are designed for injured or ailing muscles and its use on such muscles is contraindicated. For both models, electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via 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 of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. Both models may therefore be considered a technique of muscle training.
    Device Description
    The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on electrical muscle stimulation (EMS) technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.
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    K Number
    K221200
    Device Name
    XBody Go USA, XBody Pro USA
    Manufacturer
    XBody Hungary Kft.
    Date Cleared
    2023-01-31

    (280 days)

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

    XBody Hungary Kft.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XBODY Go USA and XBODY Pro USA is a machine with electronic muscle stimulation based on EMS technology. 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 XBODY Go USA and XBODY Pro USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY Go USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The XBODY Go USA and XBODY Pro USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber respond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the XBODY Go USA and XBODY Pro USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY Go USA and XBODY Pro USA may therefore be considered a technique of muscle training.
    Device Description
    The XBody Go USA and the XBody Pro USA generate electronic muscle stimulation based on EMS technology. The devices are designed as additions to other sports and for training muscles. They are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. They are intended for use only by persons with healthy muscles, not for rehabilitation purposes.
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    K Number
    K190038
    Device Name
    Xbody Newave USA
    Manufacturer
    XBody Hungary Kft.
    Date Cleared
    2019-04-05

    (87 days)

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

    XBody Hungary Kft.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XBODY NEWAVE USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and people (clients), not for rehabilitation purposes. The XBODY NEWAVE USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBODY NEWAVE USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY NEWAVE USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The XBODY NEWAVE USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the XBODY NEWAVE USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY NEWAVE USA may therefore be considered a technique of muscle training.
    Device Description
    The XBODY NEWAVE USA is a machine with electronic muscle stimulation based on EMS technology. 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.
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