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510(k) Data Aggregation

    K Number
    K231368
    Device Name
    Bemer Therapy System Evo
    Manufacturer
    Date Cleared
    2023-06-09

    (29 days)

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

    Bemer INT AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance
    Device Description
    BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation. BEMER Therapy System Evo improves local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance. The device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use. This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo. The device contains firmware that controls the user interface. It also contains the pulse generator, battery charger, audio and pushbutton controller.
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