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

    QUICKIE RHYTHM

    K Number: K083249 · Decision Dec 23, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    10
    Review Days
    49

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    Basic Information

    Device Name
    QUICKIE RHYTHM
    K Number
    K083249
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sunrise Medical Hhg, Inc.
    Date Received
    November 4, 2008
    Decision Date
    December 23, 2008
    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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