BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    SMART-DX

    Reg #: 3005998761 · FEI: 3005998761 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BTS SPA
    Registration Number
    3005998761
    FEI Number
    3005998761
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA CAPRICCIO 3/A
    City
    VIGONZA Padova
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K131660

    Owner / Operator

    Firm Name
    BTS S.p.A.
    Operator Number
    9091843
    Address
    VIA CAPRICCIO 3/A, --
    City
    VIGONZA
    State
    Padova
    Postal Code
    35010
    Country
    IT
    Correspondent
    BRUNO - ROS

    US Agent

    Business Name
    MACLIN POWER INC.
    Contact Name
    Christian Costantini
    Address
    1465 Nw 97th Avenue
    City
    West Miami
    State
    FL
    ZIP
    33172
    Country
    US
    Email
    [email protected]
    Phone
    786 8187337

    Products

    Device Name Product Code
    Interactive Rehabilitation Exercise Devices LXJ

    Proprietary Names

    SMART-DX SMART-DX EVO

    Establishment Types

    Manufacture Medical Device