BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Utopia Gear

    DI: 00862081000368 · Model: Pro 4.0 · MIDWESTERN SOLUTIONS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Utopia Gear
    Primary DI
    00862081000368
    Version / Model
    Pro 4.0
    Company Name
    MIDWESTERN SOLUTIONS
    Labeler DUNS
    048681673
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-24
    Public Version
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    8cbcfc41-3a72-4bcd-badc-7ecc43c4d71b

    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
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Package 00862081000375
    Primary 00862081000368

    Premarket Submissions

    Submission Number Supplement Number
    K143268 000