BEUDAMED
    Product Code: JXK FDA class 3 21 CFR 882.5800

    Cranial Electrotherapy Stimulator To Treat Depression

    Neurology

    Cranial Electrotherapy Stimulator to Treat Depression is a non-invasive neurological device that delivers low-level electrical current to the head to modulate brain activity for the treatment of depression. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) demonstrating safety and effectiveness, reflecting the significant risk associated with electrical brain stimulation for psychiatric indications. The product code is JXK, regulated under 21 CFR 882.5800, and falls within the Neurology medical specialty.

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    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    JXK
    Device Class
    FDA class 3
    Regulation Number
    882.5800
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    2

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.