BEUDAMED
    FDA Registration Active 🇺🇸 United States

    COMPLETE CONTROL System Gen2

    Reg #: 3010605876 · FEI: 3010605876 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Coapt LLC
    Registration Number
    3010605876
    FEI Number
    3010605876
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    303 W. Institute Pl., Suite 200
    City
    Chicago
    State
    IL
    ZIP
    60610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191083

    Owner / Operator

    Firm Name
    Coapt, LLC
    Operator Number
    10045459
    Address
    303 W. Institute Pl., Suite 200
    City
    Chicago
    State
    IL
    Postal Code
    60610
    Country
    US
    Correspondent
    Blair Lock

    Products

    Device Name Product Code
    Hand, External Limb Component, Powered IQZ
    Electrode, Cutaneous GXY

    Proprietary Names

    COMPLETE CONTROL System Gen2

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device