BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SX230FW EMG Sensor

    DI: 05060481691468 · Model: SX230FW · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SX230FW EMG Sensor
    Primary DI
    05060481691468
    Version / Model
    SX230FW
    Catalog Number
    bandwidth 20-460 plastic connector
    Company Name
    BIOMETRICS LIMITED
    Labeler DUNS
    519969810
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-09
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    0a721a05-df9f-4cc3-b6e3-09f6d891b3cd

    Device Description

    The SX230FW EMG Sensors connect to the Biometrics Ltd DataLOG, DataLINK or K800 as well as to third party instruments. The EMG Amplifier (SX230FW) uses disposable electrodes and has a variable electrode distance. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 SX230FW EMG Sensor (Gain 1000, Bandwidth 20-460Hz) - Plastic connector

    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
    Yes
    Has Serial Number
    No
    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
    HCC Device, Biofeedback

    GMDN Terms

    Code Name
    11474 Electromyograph

    Identifiers

    Type ID
    Primary 05060481691468