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

    TRX-CG POWER TILT AND RECLINE SYSTEM

    K Number: K994241 · Decision Jan 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    TRX-CG POWER TILT AND RECLINE SYSTEM
    K Number
    K994241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Motion Concepts
    Date Received
    December 15, 1999
    Decision Date
    January 13, 2000
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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