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510(k) Data Aggregation

    K Number
    K222386
    Device Name
    Visionbody
    Manufacturer
    Date Cleared
    2023-02-24

    (200 days)

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

    VB Technologies AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Visionbody System is a device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Visionbody System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed or ailing muscles and its use on such muscles is contraindicated. The Visionbody System's 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 generated 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 Visionbody System is a wireless electrical muscle stimulation device for health and fitness applications. The main components are the Visionbody Box, the Visionbody Software and the choice of a Visionbody garment, whether a Visionbody Powersuit, Visionbody PowerPants or Visionbody Power Vest, dependent on a user's personal choice and needs. The Visionbody Box delivers a safe low to mid frequency electrical current to the electrodes in a Visionbody garment. The Visionbody uses electrical muscle stimulation (EMS) and electrical muscle activation (EMA) technologies to provide a streamlined approach to a user's fitness goals, especially regarding body composition, strength and endurance. Underlying to both these technologies are safe electrical impulses, which stimulate muscle contractions equating to muscle workouts.
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