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

    POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM

    K Number: K911151 · Decision May 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM
    K Number
    K911151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Tarsys Engineering, Inc.
    Date Received
    March 15, 1991
    Decision Date
    May 29, 1991
    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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    Other Clearances by Tarsys Engineering, Inc.

    K Number Device Name
    K911152 QUAD-LINK RETRACTABLE MOUNT