BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    geko

    DI: 05060294770503 · Model: K-1 · FIRSTKIND LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    geko
    Primary DI
    05060294770503
    Version / Model
    K-1
    Catalog Number
    MK1RW02
    Company Name
    FIRSTKIND LTD
    Labeler DUNS
    216603021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-20
    Public Version
    3
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    d81b883e-beca-40c0-b2f6-4cbd710c70a8

    Device Description

    Knee Strap

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IPF Stimulator, Muscle, Powered

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 05060294770503

    Premarket Submissions

    Submission Number Supplement Number
    K134001 000