BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mana Flexx

    DI: 06971712725182 · Model: SM9187 · Hong Qiangxing (Shen Zhen) Electronics Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    60

    Basic Information

    Brand Name
    Mana Flexx
    Primary DI
    06971712725182
    Version / Model
    SM9187
    Company Name
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Labeler DUNS
    421286946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    60
    Record Status
    Published
    Publish Date
    2023-05-30
    Public Version
    1
    Public Version Date
    2023-06-07
    Public Version Status
    New
    Public Device Record Key
    a176139e-7708-4b1f-9694-4413d3fab6c1

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    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
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

    GMDN Terms

    Code Name
    46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

    Identifiers

    Type ID
    Unit of Use 06971712725175
    Primary 06971712725182

    Premarket Submissions

    Submission Number Supplement Number
    K121719 000