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510(k) Data Aggregation

    K Number
    K250896

    Validate with FDA (Live)

    Device Name
    Aura Wave
    Manufacturer
    Aura Wellness, LLC
    Date Cleared
    2025-12-02

    (252 days)

    Product Code
    SGT
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    All
    Reference & Predicate Devices
    K220938,K210174
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aura Wave is indicated:

    • To temporarily increase local blood circulation in healthy leg muscles
    • To stimulate healthy muscles in order to improve or facilitate muscle performance
    Device Description

    The Aura Wave 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 Aura Wave 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 Aura Wave has five accessory attachments (coils). The attachments vary in size and form which allows the operator to choose which attachment administers optimal treatment to the desired anatomical part of the body.
    The device contains firmware that controls the user interface. Through this user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment.

    AI/ML Overview

    N/A

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