BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Neurolutions Upper Extremity Rehabilitation System

    K Number: DEN200046 · Decision Apr 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    274

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    Basic Information

    Device Name
    Neurolutions Upper Extremity Rehabilitation System
    K Number
    DEN200046
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    890.5420
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Neurolutions, Inc.
    Date Received
    July 23, 2020
    Decision Date
    April 23, 2021
    Product Code
    QOL
    Advisory Committee
    Neurology
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QOL Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser