BEUDAMED
    Product Code: QHH FDA class 2 21 CFR 876.5340

    Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)

    Gastroenterology, Urology

    The Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (IBS) is a device that stimulates nerves remotely from the source of pain to relieve functional abdominal pain, specifically excluding devices designed for pelvic pain relief. It is classified as FDA Class 2, requiring 510(k) premarket notification, and falls under the Gastroenterology and Urology medical specialty. The product code is QHH, regulated under 21 CFR 876.5340. The device is non-implanted and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    4
    Years Active
    6

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    Basic Information

    Product Code
    QHH
    Device Class
    FDA class 2
    Regulation Number
    876.5340
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K252024 NeurAxis IB-Stim (01-1020)
    K250451 NeurAxis IB-Stim (01-1020)
    K241533 NeurAxis IB-Stim (01-1020)
    K230526 TEA Device
    K202940 First Relief v1
    DEN180057 IB-Stim

    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.