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510(k) Data Aggregation

    K Number
    K113164
    Device Name
    DISCOVERY TMAX MANUAL WHEELCHAIR
    Manufacturer
    OTTO BOCK HEALTHCARE, LP
    Date Cleared
    2013-03-11

    (502 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK HEALTHCARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tmax wheelchair are suitable for patients with walking impediments/inability due to, but not limited to: - Palsies/Paralyses . - Loss of limbs . - Defective and/or deformed limbs . - Joint contractures . - Joint defects . - Other diseases .
    Device Description
    The Discovery Tmax is a manually operated, self/attendant propelled, mechanical wheelchair. It is intended exclusively for the adaptation of orthopedic seating systems (e.g. seating shells) for people who are unable to walk or have walking impediments. The Discovery Tmax can be used indoors and outdoors. In order to provide an optimized, individual fitting, the product is adjustable and/or adaptable. The Discovery Tmax consists of a non-folding frame of aluminum, large wheels with hand rims, and small front pivoting casters. The width, depth, and height of seat are adjustable in 1 inch increments. The armrest is made of Polyurethane soft integral foam and is adjustable. It also has an adjustable backrest and removable footrest. The Discovery Tmax includes a "Tilt in space" feature which allows the seat to be tilted. The seat angle can be adjusted from -5° to +50° in increments of 2.5°. The desired seat angle is achieved by moving the push handles/ push bar. The angle can be read from the angle indicator on the hole channel.
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    K Number
    K111278
    Device Name
    Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
    Manufacturer
    OTTO BOCK HEALTHCARE, LP
    Date Cleared
    2011-09-16

    (134 days)

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

    OTTO BOCK HEALTHCARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide mobility to persons physically challenged and limited to sitting positions due to: - Palsies/Paralyses . - Loss of limbs - Defective and/or deformed limbs ● - Joint contractures . - Joint defects ● - . Other diseases
    Device Description
    The z10 is a powerful push and brake assist for manual wheelchairs. It can also be converted into the z10-ce add-on drive with tiller control quickly and easily. In this product version, the user drives and controls the wheelchair independently.
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    K Number
    K111045
    Device Name
    CENTRO FAMILY OF MANUAL WHEELCHAIRS
    Manufacturer
    OTTO BOCK HEALTHCARE, LP
    Date Cleared
    2011-07-15

    (91 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK HEALTHCARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Centro wheelchairs are designed solely for individual use by persons who are unable to walk or who have a walking impediment, and can be operated either by the patient or by another person. Centro wheelchairs are suitable for patients with walking impediments/inability due to, but not limited to: - . Palsies/Paralyses - . Defective and/or deformed limbs - Loss of limb (leg amputation) . - . Joint contractures/defects - Diseases such as cardiac or circulatory insufficiency, balance disorders . or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.
    Device Description
    The Centro Wheelchairs are an uncomplicated line of wheelchair (S1 and A3 models) and are appropriate for short-term use. The Centro wheelchairs are very robust, which ensures that they will have a long service life. The product has a functional knee lever lock. The stable cross brace ensures that it folds easily. Thus, the Gentro can be folded to a very small size easily, and it is convenient to transport or space-saving for storage. The Centro with 124 rear wheels offers the possibility to use it as a functional transit wheelchair. Due to the nylon covering of seat and back upholstery, the chairs are easy to clean or disinfect and thus always quickly ready for use.
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    K Number
    K070318
    Device Name
    SKIPPI POWERED WHEELCHAIR FOR CHILDREN
    Manufacturer
    OTTO BOCK HEALTHCARE, LP
    Date Cleared
    2007-05-11

    (98 days)

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

    OTTO BOCK HEALTHCARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide mobility to persons physically challenged and limited to sitting positions.
    Device Description
    The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG. The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires. Options available to the end user are the following: Seat Tilt Mechanism, Electric or with Gas Compression Spring. Electric Backrest Angle Adjustment. Seating Shell Adapter. Tray. Control for Attendant. Bumper Bar. Single Panel Footrest. Colors (Yellow, Blue, or Red).
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    K Number
    K052706
    Device Name
    A-200 POWERED WHEELCHAIR
    Manufacturer
    OTTO BOCK HEALTHCARE, LP
    Date Cleared
    2005-12-27

    (90 days)

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

    OTTO BOCK HEALTHCARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide mobility to persons physically challenged and limited to sitting positions.
    Device Description
    The A-200 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK Health Carc. The A-200 has a closed "U" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.
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