BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    NEUROTONUS PORTABLE TENS FES

    Reg #: 3010362721 · FEI: 3010362721 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Ibramed Industria Brasileira de Equipamentos Medicos Ltda
    Registration Number
    3010362721
    FEI Number
    3010362721
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ave Dr. Carlos Burgos 2800, Jardim Italia
    City
    Amparo Sao Paulo
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K131923

    Owner / Operator

    Firm Name
    Ibramed Industria Brasileira de Equipamentos Medicos Ltda
    Operator Number
    10043478
    Address
    Ave Dr. Carlos Burgos 2800, Jardim Italia
    City
    Amparo
    State
    Sao Paulo
    Postal Code
    13901-080
    Country
    BR
    Correspondent
    Ricardo Souza

    US Agent

    Business Name
    United Regulatory & Logistics LLC
    Contact Name
    Rodrigo Abreu
    Address
    2950 W Cypress Creek Rdd #110
    City
    Fort Lauderdale
    State
    FL
    ZIP
    33309
    Country
    US
    Email
    [email protected]
    Phone
    786 2667900

    Products

    Device Name Product Code
    Stimulator, Neuromuscular, External Functional GZI
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ

    Proprietary Names

    NEUROTONUS PORTABLE TENS FES NEURODYN PORTABLE TENS NFES NEUROTONUS PORTABLE TENS NEURODYN PORTABLE TENS

    Establishment Types

    Manufacture Medical Device