BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Low-Frequency Therapy Instrument

    DI: 06924607700535 · Model: KTR-201 · Shenzhen Kentro Medical Electronics Co.,Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Low-Frequency Therapy Instrument
    Primary DI
    06924607700535
    Version / Model
    KTR-201
    Company Name
    Shenzhen Kentro Medical Electronics Co.,Ltd
    Labeler DUNS
    544395368
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-11
    Public Version
    4
    Public Version Date
    2019-10-23
    Public Version Status
    Update
    Public Device Record Key
    90d57e6e-eb96-4a4e-a569-4d572f4df694

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

    GMDN Terms

    Code Name
    35372 Analgesic transcutaneous electrical nerve stimulation system

    Identifiers

    Type ID
    Primary 06924607700535

    Premarket Submissions

    Submission Number Supplement Number
    K170205 000