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

    PRESSUREGUARD IV

    K Number: K972486 · Decision Feb 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    16
    Applicant Total
    19
    Review Days
    233

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    Basic Information

    Device Name
    PRESSUREGUARD IV
    K Number
    K972486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5225
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Span-America Medical Systems, Inc.
    Date Received
    July 2, 1997
    Decision Date
    February 20, 1998
    Product Code
    IKZ
    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
    IKZ Bed, Patient Rotation, Powered

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    Other Clearances by Span-America Medical Systems, Inc.

    K Number Device Name
    K973169 PRESSURE GUARD SITE SELECT (A)
    K960188 PRESSUREGUARD: SELECTCARE
    K961502 LUBRICATING JELLY, LOW VISCOSITY
    K961159 POWERED LOW AIR LOSS MATTRESS SYSTEM
    K960620 PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
    K960189 GEL-T CUSHION
    K954766 PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
    K953503 PRESSUREGUARD IV
    K954117 CUSTOMCARE SEATING SYSTEM
    K951112 PRESSUREGUARD IV
    Search all 19 clearances from Span-America Medical Systems, Inc. →