BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Beactive Brace

    K Number: K151476 · Decision Feb 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    Beactive Brace
    K Number
    K151476
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Natures Pillows, Inc.
    Date Received
    June 2, 2015
    Decision Date
    February 26, 2016
    Product Code
    PMV
    Advisory Committee
    Physical Medicine
    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
    PMV Orthosis, Limb, For Back Pain