BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-LINK Hand Kit

    DI: 05060481690041 · Model: H500 · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-LINK Hand Kit
    Primary DI
    05060481690041
    Version / Model
    H500
    Company Name
    BIOMETRICS LIMITED
    Labeler DUNS
    519969810
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-14
    Public Version
    3
    Public Version Date
    2018-06-26
    Public Version Status
    Update
    Public Device Record Key
    41a3ea93-db4d-4032-b9e0-83e322190fd2

    Device Description

    The E-LINK Hand Kit which includes a Dynamometer and Pinchmeter for monitoring grip and pinch strength, is the ideal module to quantify and monitor the effectiveness of various interventions for the upper extremity, throughout the whole rehabilitation process. The Hand Kit can also be used with the E-LINK Activities (Games), for innovative isometric grip and pinch exercises that are totally focused on the individual patient. The Hand Kit (H500) is available with either a wireless or wired interface

    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISD Exerciser, Measuring

    GMDN Terms

    Code Name
    33785 Hand dynamometer/pinchmeter, electronic

    Identifiers

    Type ID
    Primary 05060481690041