BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AXION USA LLC

    Reg #: 3027329006 · FEI: 3027329006 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    AXION USA LLC
    Registration Number
    3027329006
    FEI Number
    3027329006
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    120 Raskulinecz Rd
    City
    Carteret
    State
    NJ
    ZIP
    07008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160138

    Owner / Operator

    Firm Name
    Axion USA
    Operator Number
    10088047
    Address
    1309 Coffeen Avenue STE 1200
    City
    Sheridan
    State
    WY
    Postal Code
    82801
    Country
    US
    Correspondent
    Marco Veser

    Products

    Device Name Product Code
    Tape And Bandage, Adhesive KGX
    Electrode, Cutaneous GXY
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Electrical, Non-Implantable, For Incontinence KPI
    Media, Electroconductive GYB

    Proprietary Names

    Axion Kinesiology Band Stim Pro axion Axion Stim-Pro Comfort Axion Stim-Pro I-2000 STIM-PRO I-3000 Axion USA LLC

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility