BEUDAMED
    Product Code: QYN FDA class 1 21 CFR 890.5775

    Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)

    Physical Medicine
    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    QYN
    Device Class
    FDA class 1
    Regulation Number
    890.5775
    Medical Specialty
    Physical Medicine
    Review Panel
    NE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN250005 Sana Device