BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    TEC.BEAN

    DI: 06970890320011 · Model: AS1080 · Shenzhen As-Tec Technology Co.,Ltd.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TEC.BEAN
    Primary DI
    06970890320011
    Version / Model
    AS1080
    Company Name
    Shenzhen As-Tec Technology Co.,Ltd.
    Labeler DUNS
    421355284
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-19
    Public Version
    10
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    851d458a-12a2-4ef0-ad0d-8619d42bc5c7
    Distribution End Date
    2021-05-04

    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
    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
    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
    Package 06970890329283
    Primary 06970890320011

    Premarket Submissions

    Submission Number Supplement Number
    K143268 000