BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    REVOLUTION LOWER LIMB CPM UNIT

    K Number: K935808 · Decision Mar 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    REVOLUTION LOWER LIMB CPM UNIT
    K Number
    K935808
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Toronto Medical, Inc.
    Date Received
    December 2, 1993
    Decision Date
    March 18, 1994
    Product Code
    BXB
    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
    BXB Exerciser, Powered

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