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

    HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P

    K Number: K102236 · Decision Nov 18, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    101

    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
    HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
    K Number
    K102236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3690
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
    Date Received
    August 9, 2010
    Decision Date
    November 18, 2010
    Product Code
    INK
    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
    INK Stretcher, Wheeled, Powered

    Similar 510(k) Clearances

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

    Winco Model S550 Stretchair

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PRIME ZOOM STRETCHER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PROCEDURAL STRECHER WITH INTELLIDRIVE P8000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    WINCO STRETCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POWER DRIVE CHAIR, MODEL: TMM6

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777

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

    Other Clearances by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L

    K Number Device Name
    K121287 HT-WEDGE