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

    BioniCare Hand System

    K Number: K142236 · Decision Mar 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    222

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    Basic Information

    Device Name
    BioniCare Hand System
    K Number
    K142236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vision Quest Industries, Inc.
    Date Received
    August 13, 2014
    Decision Date
    March 23, 2015
    Product Code
    NYN
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NYN Stimulator, Electrical, Transcutaneous, For Arthritis

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