BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GREAT LAKES NEUROTECHNOLOGIES INC.

    Reg #: 3009134706 · FEI: 3009134706 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GREAT LAKES NEUROTECHNOLOGIES INC.
    Registration Number
    3009134706
    FEI Number
    3009134706
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6100 Rockside Woods Blvd., Suite 415
    City
    Cleveland
    State
    OH
    ZIP
    44131
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063872

    Owner / Operator

    Firm Name
    Great Lakes NeuroTechnologies Inc.
    Operator Number
    10035940
    Address
    6100 Rockside Woods Blvd., Suite 415
    City
    Cleveland
    State
    OH
    Postal Code
    44131
    Country
    US
    Correspondent
    Dustin Heldman

    Products

    Device Name Product Code
    Transducer, Tremor GYD

    Proprietary Names

    Kinesia ONE KinesiaU Kinesia 360 Kinesia ProView Kinesia HomeView Kinesia StimPoint Kinesia Kinesia ONE-C

    Establishment Types

    Manufacture Medical Device