BEUDAMED
    Product Code: OAA FDA not classified

    Aid, Visual, For Nausea

    Unknown

    The Aid, Visual, For Nausea (product code OAA) is a device intended to relieve symptoms associated with motion sickness through a visual mechanism. The FDA has determined it is not classified as a regulated medical device (Class N / not classified), reviewed by the Ear, Nose, and Throat (ENT) panel, and falls outside the scope of formal device classification. The device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OAA
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    EN
    Submission Type
    7

    Device Characteristics

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

    Definition

    To relieve the symptoms associated with motion sickness.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.