BEUDAMED
    Product Code: QNO FDA class 2 21 CFR 872.5575

    Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

    Dental

    The Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea is a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue, strengthening tongue musculature to reduce snoring and obstructive sleep apnea. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 872.5575 in the Dental specialty. It carries product code QNO and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    3
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    2
    Years Active
    3

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    Basic Information

    Product Code
    QNO
    Device Class
    FDA class 2
    Regulation Number
    872.5575
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K240328 eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
    K223446 eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
    DEN200018 eXciteOSA with remote and eXciteOSA without remote

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.