BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Proactive Elle TENS (715-432)

    Reg #: 8022077 · FEI: 3000171642 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    AMG MEDICAL INC.
    Registration Number
    8022077
    FEI Number
    3000171642
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8505 DALTON
    City
    MONTREAL Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K190009

    Owner / Operator

    Firm Name
    AMG MEDICAL INC.
    Operator Number
    8022077
    Address
    8505 DALTON, --
    City
    MONTREAL
    State
    Quebec
    Postal Code
    H4T 1V5
    Country
    CA

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    KEVIN WALLS
    Address
    33 Golden Eagle Ln
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX

    Proprietary Names

    Proactive Elle TENS (715-432)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor