BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AXELGAARD MFG. CO., LTD.

    Reg #: 2025066 · FEI: 1000603528 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    AXELGAARD MFG. CO., LTD.
    Registration Number
    2025066
    FEI Number
    1000603528
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    520 INDUSTRIAL WAY
    City
    FALLBROOK
    State
    CA
    ZIP
    92028
    Country
    US

    Regulatory Submissions

    510(k) Number
    K080580

    Owner / Operator

    Firm Name
    Axelgaard Manufacturing Co. Ltd.
    Operator Number
    9010494
    Address
    520 INDUSTRIAL WAY, --
    City
    Fallbrook
    State
    CA
    Postal Code
    92028
    Country
    US

    Products

    Device Name Product Code
    Device, Iontophoresis, Other Uses EGJ
    Electrode, Cutaneous GXY
    Electrode, Electrocardiograph DRX

    Proprietary Names

    Buffered Iontophoresis Electrodes Comfort Iontophoresis Electrodes / UltraStim ELectrode, Model US4040 Little PALS ValuTrode OTC Neurostimulation Electrodes PALS Neurostimulation Electrodes

    Establishment Types

    Manufacture Medical Device