BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Transcutaneous Electrical Nerve Stimulator

    DI: 04897139961236 · Model: 9029SCM, 9029 · HONG KONG ETECH GROUPS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Transcutaneous Electrical Nerve Stimulator
    Primary DI
    04897139961236
    Version / Model
    9029SCM, 9029
    Company Name
    HONG KONG ETECH GROUPS LIMITED
    Labeler DUNS
    687210485
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-17
    Public Version
    1
    Public Version Date
    2024-07-25
    Public Version Status
    New
    Public Device Record Key
    68429d5a-9f6a-4829-aaec-619af3fbcedc

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

    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
    Primary 04897139961236

    Premarket Submissions

    Submission Number Supplement Number
    K240292 000