BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Aura Wave

    K Number: K250896 · Decision Dec 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    252

    Basic Information

    Device Name
    Aura Wave
    K Number
    K250896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aura Wellness, LLC
    Date Received
    March 25, 2025
    Decision Date
    December 2, 2025
    Product Code
    SGT
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SGT Electromagnetic Stimulator For Healthy Muscle Stimulation

    Other Clearances by Aura Wellness, LLC

    K Number Device Name
    K220938 Nova HD+