BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RED

    Reg #: 3009445917 · FEI: 3009293069 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    NEURAXIS, INC
    Registration Number
    3009445917
    FEI Number
    3009293069
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11611 N Meridian St, Suite 330
    City
    Carmel
    State
    IN
    ZIP
    46032
    Country
    US

    Regulatory Submissions

    510(k) Number
    K242304

    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
    System, Gastrointestinal Motility (Electrical) FFX
    Monitor, Esophageal Motility, Anorectal Motility, And Tube KLA

    Proprietary Names

    RED

    Establishment Types

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