BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iotaSOFT Insertion System - Drive Unit, Controller and Accessories

    Reg #: 3030411493 · FEI: 3030411493 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    IOTAMOTION, INC.
    Registration Number
    3030411493
    FEI Number
    3030411493
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4205 White Bear Pkwy Ste 600
    City
    Vadnais Heights
    State
    MN
    ZIP
    55110
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN190055

    Owner / Operator

    Firm Name
    iotaMotion, Inc.
    Operator Number
    10083773
    Address
    4205 White Bear Parkway, STE 600
    City
    Saint Paul
    State
    MN
    Postal Code
    55110
    Country
    US
    Correspondent
    Marie Calabria

    Products

    Device Name Product Code
    Powered Insertion System For A Cochlear Implant Electrode Array QQH

    Proprietary Names

    iotaSOFT Insertion System - Drive Unit, Controller and Accessories

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device