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510(k) Data Aggregation

    K Number
    K042104
    Device Name
    AMERICAN BANTEX, MODEL MS 3
    Manufacturer
    AMERICAN BANTEX CORP.
    Date Cleared
    2004-10-21

    (78 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN BANTEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MS 3 Mini Scooter has been designed to help people who have a difficult time walking. The MS 3 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.
    Device Description
    The American Bantex MS 3 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and single wheeled steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 3 breaks-down into several components for easy, tool less assembly, disassembly and transportation.
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    K Number
    K041963
    Device Name
    AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI
    Manufacturer
    AMERICAN BANTEX CORP.
    Date Cleared
    2004-10-20

    (91 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN BANTEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Bantex Humidifier is intended for use with oxygen concentrators or gas sources in a patients home, physicians office or hospital / institutional environment. The humidifier increases the moisture content of the airstream gases for administration directly to the patient. Single patient use only Non-sterile Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
    Device Description
    The American Bantex Humidifier is device that provides humidity in a non-heated pathway. The American Bantex Humidifier works with most all Oxygen Concentrators or to an oxygen source used in homes, doctors' office, hospital or institutional environments. The inlet uses an easy-to-grab winged styled nut that universally adapts to most all gas connections. The outlet is a push-on standard medical tubing connector with a tapered end. The American Bantex Humidifier is equipped with either a 3 or 6-PS1 safety valve that will alarm if there is a kink or blockage in the delivery system.
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    K Number
    K040754
    Device Name
    AMERICAN BANTEX MS 4 MINI SCOOTER
    Manufacturer
    AMERICAN BANTEX CORP.
    Date Cleared
    2004-07-23

    (121 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN BANTEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MS 4 Mini Scooter has been designed to help people who have a difficult time walking. The user must have use of hands and upper-body mobility. People who have some mobility, but cannot walk for long distances or people that may need crutches to walk will generally purchase this scooter. The MS 4 Mini Scooter is designed for both indoor and limited outdoor use in clean and dry conditions.
    Device Description
    The American Bantex MS 4 Mini Scooter is a Class II device that also is intended to provide assistance to individuals that are unable to walk long distances. The rear-wheel drive and two wheel steering abilities allow the user to effortlessly control this device. The body (shell) is made of rigid Acrylonitrile-Butadiene-Styrene Copolymer. The shell is available to the consumer in two colors. The variable speed dial on the tiller column enables users single-handed operation while moving forward. The sealed (24 V) transaxle motor is quiet to operate. As with the predicate device, the MS 4 breaksdown into several components for easy, tool less assembly, disassembly and transportation.
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    K Number
    K031711
    Device Name
    TANGO, MODELS, BP1
    Manufacturer
    AMERICAN BANTEX CORP.
    Date Cleared
    2003-12-18

    (199 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN BANTEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tango Series Powered Wheelchairs are indicated to provide enhanced mobility to physically challenged persons/patients who are limited to a sitting position for various medical reasons. Some, but not all of the specific indications for use for powered wheelchairs are: paraplegia, muscular sclerosis, lower limb amputation, neurologic or other muscular diseases which render lower-limbs too weak or unstable for normal use or activity.
    Device Description
    The Tango Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The two models are identical, except the frame. The BP1 has a steel frame and the BP1A has an aluminum frame. The wheelchair has four wheels, an adjustable seat with armrests, and a joystick controller for an attendant and the ability to disengage the wheel motor gear so that an attendant may use the chair as a free-wheel device. The automatic braking systems are an integral part of the controller and when the controller is released. Both models can be disassembled for easy transportation and reassembly and use.
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    K Number
    K963218
    Device Name
    BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE
    Manufacturer
    AMERICAN BANTEX CORP.
    Date Cleared
    1996-10-30

    (75 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN BANTEX CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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