BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR

    K Number: K113577 · Decision May 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    19
    Review Days
    155

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    Basic Information

    Device Name
    MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR
    K Number
    K113577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merits Health Products Co., Ltd.
    Date Received
    December 5, 2011
    Decision Date
    May 8, 2012
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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