BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    ARC-EX System - Professional US

    Reg #: 3034211447 · FEI: 3034211447 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ONWARD Medical N.V.
    Registration Number
    3034211447
    FEI Number
    3034211447
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Schimmelt 2
    City
    Eindhoven Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    DEN240014

    Owner / Operator

    Firm Name
    Onward Medical
    Operator Number
    10092025
    Address
    50 Milk Street
    City
    Boston
    State
    MA
    Postal Code
    02109
    Country
    US
    Correspondent
    Nathalie Gilat

    US Agent

    Business Name
    ONWARD MEDICAL Inc.
    Contact Name
    Nathalie Gilat
    Address
    50 Milk St
    City
    Boston
    State
    MA
    ZIP
    02109
    Country
    US
    Email
    [email protected]
    Phone
    585 3639124

    Products

    Device Name Product Code
    Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation SDO

    Proprietary Names

    ARC-EX System - Professional US

    Establishment Types

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