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510(k) Data Aggregation

    K Number
    K121287
    Device Name
    HT-WEDGE
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
    Date Cleared
    2012-10-03

    (156 days)

    Product Code
    FNG
    Regulation Number
    880.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
    Device Description
    The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.
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    K Number
    K102236
    Device Name
    HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
    Date Cleared
    2010-11-18

    (101 days)

    Product Code
    INK
    Regulation Number
    890.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
    Device Description
    The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
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