BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REUSABLE INCONTIENT UNDERPAD

    K Number: K924807 · Decision Feb 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    210
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    160

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    REUSABLE INCONTIENT UNDERPAD
    K Number
    K924807
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6190
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Perfect Fit Industries, Inc.
    Date Received
    September 3, 1992
    Decision Date
    February 10, 1993
    Product Code
    FMW
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMW Cover, Mattress (Medical Purposes)

    Similar 510(k) Clearances

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

    DermaTherapy Bed Linens

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DERMATHERAPY, MODEL 22216

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Z-NET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CORE PREVENT MATTRESS MODIFICATION

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Perfect Fit Industries, Inc.

    K Number Device Name
    K924477 WIPEABLE PILLOW