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

    OMEGATRAC, MODEL Z105

    K Number: K013307 · Decision Feb 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    8
    Review Days
    127

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    OMEGATRAC, MODEL Z105
    K Number
    K013307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teftec Corp.
    Date Received
    October 4, 2001
    Decision Date
    February 8, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ITI), ordered by most recent decision date.

    Power Wheelchair (W5915B, W5915C, W5915D)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Electric Wheelchair (S500-6)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    WHILL (WHILL Model C2)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Power Wheelchair (N5515A, N5516, N5517A, N5519)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Electric Wheelchair (DF506)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Electric Wheelchair (Y207BL)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Teftec Corp.

    K Number Device Name
    K022652 ALPHATRAC, MODEL A 205
    K993160 OMEGA TRAC, MODEL Z100
    K992628 FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
    K992627 FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
    K983066 FIRSTCLASS POWER TILT SEAT SYSTEM, MODEL S300
    K982815 ALPHATRAC, MODEL A200
    K955240 OMEGATRAC BY TEFTEC