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

    THE CRADLE

    K Number: K933964 · Decision Oct 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    413

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    Basic Information

    Device Name
    THE CRADLE
    K Number
    K933964
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5225
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Primal Energy Research Foundation
    Date Received
    August 16, 1993
    Decision Date
    October 3, 1994
    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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