BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    Sana Device

    K Number: DEN250005 · Decision Jan 16, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    319

    Basic Information

    Device Name
    Sana Device
    K Number
    DEN250005
    Device Class
    FDA class 1
    Clearance Type
    Direct
    Regulation Number
    890.5775
    Medical Specialty
    Physical Medicine
    Decision
    Unknown
    Applicant
    Sana Health
    Date Received
    March 3, 2025
    Decision Date
    January 16, 2026
    Product Code
    QYN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QYN Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)