BEUDAMED
    FDA Registration Active 🇺🇸 United States

    100,

    Reg #: 2020648 · FEI: 2020648 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ELECTROMEDICAL PRODUCTS INTL., INC.
    Registration Number
    2020648
    FEI Number
    2020648
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2201 GARRETT MORRIS PKWY.
    City
    Mineral Wells
    State
    TX
    ZIP
    76067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K903014

    Owner / Operator

    Firm Name
    ELECTROMEDICAL PRODUCTS INTL., INC.
    Operator Number
    9027065
    Address
    2201 GARRETT MORRIS PKWY., --
    City
    Mineral Wells
    State
    TX
    Postal Code
    76067
    Country
    US
    Correspondent
    Brian Burke

    Products

    Device Name Product Code
    Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety QJQ

    Proprietary Names

    100, Alpha-Stim AID, M, SCS, Trudenta Alpha-Stim M

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device