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

    OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED

    K Number: K923710 · Decision Mar 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    238

    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
    OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED
    K Number
    K923710
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5225
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Progressive Medical Technology, Inc.
    Date Received
    July 27, 1992
    Decision Date
    March 22, 1993
    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

    Similar 510(k) Clearances

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

    PRESSUREGUARD IV

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RUMORS DYNAMIC AIR THERAPY UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    THE FREEDOM BED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PULMONEX DYNAMIC AIR THERAPY UNIT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Progressive Medical Technology, Inc.

    K Number Device Name
    K915638 TALLEY TM200 INTERMTTENT COMPRESSION UNIT
    K915092 TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST
    K915637 TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST.
    K915671 B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT