BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MYOLAB II

    DI: 00885859004962 · Model: MC-200 · MOTION CONTROL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MYOLAB II
    Primary DI
    00885859004962
    Version / Model
    MC-200
    Company Name
    MOTION CONTROL, INC
    Labeler DUNS
    177661386
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-04
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    9e98b82a-2b0d-4296-8be3-6522083c4e60

    Device Description

    The Myolab II was specifically designed for use in fitting and troubleshooting the Utah Arm and ProPlus myoelectric prostheses. It can be used to locate muscle activity down to 0.2 microvolts in the remnant limb. The adjustable gain feature allows the device to test and train muscle EMG for any single or dual-channel myoelectric control system.

    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
    HCC Device, Biofeedback

    GMDN Terms

    Code Name
    10396 Biofeedback system

    Identifiers

    Type ID
    Primary 00885859004962