BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COPPER Fit

    DI: 00851640007573 · Model: JQ-5C-07A · Hi-Dow International Incorporated
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COPPER Fit
    Primary DI
    00851640007573
    Version / Model
    JQ-5C-07A
    Company Name
    Hi-Dow International Incorporated
    Labeler DUNS
    124034476
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-24
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    8cfd0a86-b30f-4539-8bbe-158b91ddbd98

    Device Description

    Electronic Muscle Stimulater

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

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

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00851640007573