BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Bionic Gym

    Reg #: 3016674228 · FEI: 3016674228 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Medical Currents Ltd
    Registration Number
    3016674228
    FEI Number
    3016674228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Cuffe Lane
    City
    Dublin
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K182794

    Owner / Operator

    Firm Name
    Medical Currents Ltd
    Operator Number
    10062764
    Address
    8 Cuffe Lane
    City
    Dublin
    State
    IE-D
    Postal Code
    D02W840
    Country
    IE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX

    Proprietary Names

    Bionic Gym

    Establishment Types

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