BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    AposTherapy System

    K Number: K182090 · Decision Nov 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    106

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    Basic Information

    Device Name
    AposTherapy System
    K Number
    K182090
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3475
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apos Medical Assets , Ltd.
    Date Received
    August 2, 2018
    Decision Date
    November 16, 2018
    Product Code
    QDT
    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
    QDT Shoe With Adjustable Sole Units