BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEURAXIS, INC

    Reg #: 3009445917 · FEI: 3009293069 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    NEURAXIS, INC
    Registration Number
    3009445917
    FEI Number
    3009293069
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11611 N Meridian St, Suite 330
    City
    Carmel
    State
    IN
    ZIP
    46032
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140530

    Owner / Operator

    Firm Name
    NeurAxis, Inc
    Operator Number
    10078247
    Address
    11611 N Meridian St, Suite 330
    City
    Carmel
    State
    IN
    Postal Code
    46032
    Country
    US
    Correspondent
    Thomas J Carrico

    Products

    Device Name Product Code
    Stimulator, Electro-Acupuncture BWK
    System, Gastrointestinal Motility (Electrical) FFX
    Monitor, Esophageal Motility, Anorectal Motility, And Tube KLA
    Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs) QHH

    Proprietary Names

    NeuroStim RED IB-Stim

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198