BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XFT, SaeboStim Pro

    DI: 06970670070228 · Model: XFT-2000, SaeboStim Pro · Shenzhen XFT Medical Limited
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    XFT, SaeboStim Pro
    Primary DI
    06970670070228
    Version / Model
    XFT-2000, SaeboStim Pro
    Company Name
    Shenzhen XFT Medical Limited
    Labeler DUNS
    526874312
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-02
    Public Version
    4
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    56d2bdcc-afb6-4c76-9784-3301f94ff3a4

    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
    MR Unsafe
    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
    IPF Stimulator, Muscle, Powered
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Primary 06970670070228

    Premarket Submissions

    Submission Number Supplement Number
    K193275 000