BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    THE FREEDOM BED

    K Number: K954671 · Decision Apr 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    174

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    Basic Information

    Device Name
    THE FREEDOM BED
    K Number
    K954671
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5225
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Probed Medical Technologies, Inc.
    Date Received
    October 10, 1995
    Decision Date
    April 1, 1996
    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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