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

    Quickie(r) Q700-UP M

    K Number: K172384 · Decision Jan 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    65
    Applicant Total
    5
    Review Days
    161

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    Basic Information

    Device Name
    Quickie(r) Q700-UP M
    K Number
    K172384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sunrise Medical (Us), LLC
    Date Received
    August 8, 2017
    Decision Date
    January 16, 2018
    Product Code
    IPL
    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
    IPL Wheelchair, Standup

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    Other Clearances by Sunrise Medical (Us), LLC

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