BEUDAMED
    Product Code: NYX FDA class 2 21 CFR 882.5890

    Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes

    Neurology

    The Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes (product code NYX) is a transcutaneous electrical stimulation device with limited output intended for aesthetic applications such as muscle toning or skin appearance improvement. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 882.5890 within the Neurology specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NYX
    Device Class
    FDA class 2
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

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

    Definition

    Electrical stimulation for aesthetic purposes