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

    IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)

    K Number: K063175 · Decision Mar 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    512

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    Basic Information

    Device Name
    IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
    K Number
    K063175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Technology Systems, Inc.
    Date Received
    October 19, 2006
    Decision Date
    March 14, 2008
    Product Code
    MOC
    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
    MOC Cushion, Flotation, Therapeutic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MOC), ordered by most recent decision date.

    ERGOSEAT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
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