BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ReGrasp

    K Number: K153163 · Decision Apr 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    60
    Applicant Total
    2
    Review Days
    157

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    Basic Information

    Device Name
    ReGrasp
    K Number
    K153163
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5810
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rehabtronics, Inc.
    Date Received
    November 2, 2015
    Decision Date
    April 7, 2016
    Product Code
    GZI
    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
    GZI Stimulator, Neuromuscular, External Functional

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