BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    E-LINK Upper Limb Exerciser

    DI: 05060481690010 · Model: E4000 · BIOMETRICS LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    E-LINK Upper Limb Exerciser
    Primary DI
    05060481690010
    Version / Model
    E4000
    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
    2018-05-11
    Public Version Status
    Update
    Public Device Record Key
    b8700fd1-f0d8-45a9-bc16-7905602dfe7d

    Device Description

    "The E-LINK Upper Limb Exerciser is designed for active and active resistive upper extremity exercise of the wrist, forearm, elbow, and shoulder. The versatility of the parameters allows rehabilitation for a wide range of orthopedic and neurological patients. The Upper Limb Exerciser is available with either a wireless or wired interface to the computer."

    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
    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
    ION Exerciser, Non-Measuring
    ISD Exerciser, Measuring

    GMDN Terms

    Code Name
    63314 Electronic torsional hand exerciser

    Identifiers

    Type ID
    Primary 05060481690010