BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Personal Kinetigraph System Gen 2 Plus

    Reg #: 3011196543 · FEI: 3011196543 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    GKC MANUFACTURING PTY LTD
    Registration Number
    3011196543
    FEI Number
    3011196543
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Level 9, 31 Queen Street
    City
    Melbourne Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K211887

    Owner / Operator

    Firm Name
    Global Kinetics USA Corporation
    Operator Number
    10047497
    Address
    5775 Wayzata Blvd, Suite 700
    City
    St Louis Park
    State
    MN
    Postal Code
    55416
    Country
    US
    Correspondent
    Dane Mellan

    Products

    Device Name Product Code
    Reminder, Medication NXQ
    Transducer, Tremor GYD
    Exerciser, Measuring ISD

    Proprietary Names

    Personal Kinetigraph System Gen 2 Plus Personal Kinetigraph System PKG

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device