BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TENS MAKER

    DI: 04719880810123 · Model: WE-201 · HIVOX BIOTEK INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TENS MAKER
    Primary DI
    04719880810123
    Version / Model
    WE-201
    Company Name
    HIVOX BIOTEK INC.
    Labeler DUNS
    658030473
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-22
    Public Version
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    3c9fd98b-94fd-4435-96df-66ae42f9f781

    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 04719880810123

    Premarket Submissions

    Submission Number Supplement Number
    K141921 000