BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Homedics

    DI: 00198715239751 · Model: TENS-160J · Shenzhen Yiran Intelligence Co., Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Homedics
    Primary DI
    00198715239751
    Version / Model
    TENS-160J
    Company Name
    Shenzhen Yiran Intelligence Co., Ltd.
    Labeler DUNS
    707408239
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-20
    Public Version
    1
    Public Version Date
    2025-01-28
    Public Version Status
    New
    Public Device Record Key
    0d418554-c0f7-408e-bd9a-9fff003e1a67

    Device Description

    TENS & EMS pain therapy device

    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
    No
    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
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 00198715239751