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510(k) Data Aggregation

    K Number
    K220938
    Device Name
    Nova HD+
    Manufacturer
    Date Cleared
    2023-08-22

    (509 days)

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

    Aura Wellness, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
    Device Description
    The Nova HD+ system is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles in order to improve and facilitate muscle performance. The Nova HD+ is noninvasive, fully reusable (no disposable components such as electrodes) and have configurations allowing both home care and clinical professional use. In addition to the main control unit, the Nova HD+ includes a large loop coil applicator (coils) which allow the operator to administer optimal treatment to the desired anatomical part of the body. The device contains firmware that controls the user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment.
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