BEUDAMED
    Product Code: PIM FDA class 3

    Neuromodulator For Obesity

    Unknown

    The Neuromodulator for Obesity is an implantable device intended to achieve weight reduction through peripheral neuromodulation, using electrical or similar stimulation to modulate neural activity associated with appetite and metabolism. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA) due to the high risk associated with implantable neuromodulatory devices for obesity treatment. The product code is PIM, reviewed by the Gastroenterology and Urology (GU) panel, and is flagged as an implant. No regulation number or medical specialty has been formally assigned.

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

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    Basic Information

    Product Code
    PIM
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    Weight reduction by peripheral neuromodulation.

    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.