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510(k) Data Aggregation

    K Number
    K101524
    Device Name
    C2000 POWERED WHEELCHAIR
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2010-09-29

    (119 days)

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

    OTTO BOCK HEALTH CARE, 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 C2000 power wheelchair is suitable for indoor and outdoor use. It is compactly designed and easy to maneuver for use indoors. Two 12 V batteries power its high-performance drive system, which allows the C2000, along with spring mounted drive wheels, to overcome obstacles (category C of EN 12184) and to ensure safe operation. The C2000 power wheelchair is controlled by an enAble50 wheelchair control system. It includes a control panel to enter driving commands and display the current status as well as a controller that controls that drive motors and other electrical functions based on the input data. Data transmission is realized via a bus system. The enAble50 can be programmed to the personal requirements of the user; e. g. the speed, acceleration and deceleration values can all be personalized.
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    K Number
    K082314
    Device Name
    BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2008-10-28

    (76 days)

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

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Children who are unable to walk or who have a walking impediment.
    Device Description
    The BRAVOracer is a lightweight, adaptive, and multifunctional wheelchair. It was designed for children who are unable to walk or who have a walking impediment. This wheelchair can be moved either by the patient him/herself or by another person. The BRAVOracer is a rigid frame of aluminum.Seat height is front and rear adjustable, with various widths and heights. It has a width of 47-66 cm. The seat material is nylon upholstery. All backs are adjustable and all armrests are removable. It has a swing-away footrest with a weight capacity of 60 kg or approximately 132 pounds.
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    K Number
    K073512
    Device Name
    START JUNIOR
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2008-01-14

    (31 days)

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

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Children who are unable to walk or who have a walking impediment.
    Device Description
    Manual Wheelchair
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    K Number
    K052771
    Device Name
    SENSOR WALK
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2006-05-03

    (215 days)

    Product Code
    IQI, IOI
    Regulation Number
    890.3475
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SensorWalk is intended to lock the knee joint during the stance phase and to unlock the knee joint during the swing phase when walking forward on level surfaces. It is intended solely for the orthotic fitting of the lower limbs of patients who are community ambulators and who: - Exhibit knee instability in the sagittal plane while bearing weight during the stance phase of their gait cycle; - Have hip extensor strength of at least grade 3 (against gravity); - Have the muscle strength in their torso or pelvis required to swing the SensorWalk forward while they are walking; - Have a gait in which the step length on level ground exceeds the length of the opposing foot; - Weigh 300 pounds or less; and - Are able to understand and carry out the instructions.
    Device Description
    The Sensor Walk is a microprocessor-controlled Knee Ankle Foot Orthosis (KAFO) designed to help wearers achieve a safer, more physiologically correct gait. It does this by unlocking the knee joint when the wearer is ready for swing phase and locking it again for stability during stance phase. The Sensor Walk system includes an onboard microprocessor, a clutch spring knee joint, foot pressure sensors, a knee angle sensor, a battery, and a battery charger. When the sound limb has been loaded during walking and the affected side is about to enter swing phase (with the toe still on the ground) the microprocessor reads signal information from the foot and knee sensors and allows the knee to go into flexion. When the orthosis begins to extend again, the knee will enter a stable phase, preventing any flexion while allowing full extension for stance phase. The Sensor Walk will support the wearer if they load it at any point while it is extending, offering them exceptional stability. Wearers can disengage the knee joint, such as for sitting, simply by pressing the manual release switch. The Sensor Walk offers 12 hours of continuous use before it needs to be recharged, and contains an audible warning to alert the use if the battery is running low. When the Sensor Walk is turned off, it offers the stability of a traditional locked KAFO throughout the gait cycle. The Sensor Walk has Manual Release Function. A control collar at the knee joint can be manually pushed back to temporarily override the locking mechanism and put the joint into free swing mode. As soon as the collar is reling meetialism und be able to lock. To override the Sensor Walk's locking mechanism for a longer period, a Manual Release Rocker Switch can be pressed to lock the control collar in the free swing mode. When the Manual Release Rocker Switch is pressed and the joint is in free-swing mode, the switch will show an amber dot to indicate that caution should be used. In normal operating mode, the switch will show a green dot indicating that the locking feature will function normally. The Sensor Walk™ is comprised of the following parts: a traditional, doubleupright KAFO with a free-articulating medial knee joint; a lateral mechanical clutch, 6 spring knee joint, microprocessor-controlled electronics, foot sensors, a battery, and a battery charger. The foot sensor plate includes 4 sensors arranged in a straight line on the bottom of the foot plate. They are numbered from 1 to 4, beginning with the most posterior. The sensors overlap by 3/8 inch (10mm), and are wired to a sensor selection switch located in the electronics of the Sensor Walk. The Sensor Walk comes delivered with sensors 1 and 2 activated, but, if necessary, other sensors can be selected to optimize patient fitting. The Sensor Walk is delivered with the following components: - Fabricated KAFO with Sensor Walk (17B500) knee joint and foot sensor (520E500) - Battery (517B20) and Charger (517L20) - Sensor Walk Instructions for Use The Sensor Walk comes in either a right or left, laminated or thermoplastic. The Order Numbers are as follows: - 17B500 == R-L300 == Laminated Right - 17B500 = L-L300 Laminated Left - 17B59() = R-T300 Thermoplastic Right - 178500 -- L-T300 -- Thermoplastic Left
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    K Number
    K052681
    Device Name
    START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2005-10-06

    (8 days)

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

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Persons who are unable to walk or who have a walking impediment.
    Device Description
    Not Found
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    K Number
    K041208
    Device Name
    POWERED WHEELCHAIR, MODEL B-500
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2004-10-01

    (144 days)

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

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide mobility to persons physically challenged and limited to sitting position.
    Device Description
    The B-500 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-500 has an "H" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.
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    K Number
    K041210
    Device Name
    POWERED WHEELCHAIR, MODEL B-600
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2004-10-01

    (144 days)

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

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide mobility to persons physically challenged and limited to sitting position.
    Device Description
    The B-600 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-600 has an "H" frame, controlled by Curtis Instruments Controller, electronic regenerative disc brakes, and Micro Motor.
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    K Number
    K041211
    Device Name
    POWERED WHEELCHAIR, MODEL C-1000
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2004-10-01

    (144 days)

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

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provide mobility to persons physically challenged and limited to sitting position.
    Device Description
    The C-1000 Powered Wheelchair is a front wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The C-1000 has an "H" frame, controlled by a Curtis Instruments MC-2, electronic regenerative disc brakes and Micro Motor.
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    K Number
    K041215
    Device Name
    CRANIAL HELMET
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2004-09-09

    (122 days)

    Product Code
    MVA
    Regulation Number
    882.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cranial Helmet (cranial orthosis) is a device that is intended for medical purposes to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. Contraindications: Infants with Synostosis or Hydroccphalus. Prescription Device.
    Device Description
    The Cranial Helmet is a cranial orthosis custom fabricated to apply pressure to the prominent regions of an infant's cranium to improve cranial symmetry and shape. The Cranial Helmet is comprised of the same materials as the P.A.P. Orthosis (K012804). It is not packaged for sale, as it is custom fabricated. It will be fitted to the infant at the time of delivery. The Cranial Helmet has no accessories, and no options are available for the infant or the caregiver (parent). Caregivers are instructed as to: wear, care, cautions, and risks. The transparent thermoplastic is Surlyn which varies in thickness from 1/8 inch to 3/8 inch depending upon the desired characteristics. The helmet is fabricated from a cast taken of an infant's head. There are no standard sizes, models, variances, etc. A polyurethane foam strip is applied to the posterior border at the base of the occipital to provide suspension and anti-rotation. Each Cranial Helmet is fastened with a Velcro strap. Each infant with a Cranial Helmet must be under the care of a physician. The helmet is a Prescription Device.
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    K Number
    K032833
    Device Name
    MYOSYSTEM WITH CUSTOMIZING
    Manufacturer
    OTTO BOCK HEALTH CARE, LP
    Date Cleared
    2003-09-23

    (12 days)

    Product Code
    GXY, IQZ
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK HEALTH CARE, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Adult External Electric Upper Extremity System
    Device Description
    The MyoSystem with Customizing is an adult external electric upper extremity system which allows the CPO to adjust all relevant parameters of the control of an external powered upper extremity prosthesis by a Personal Computer (PC). The system allows the connection of the control of a prosthesis with a PC by serial communication. A PC Software program allows the monitoring of how the patient performs with the prosthesis and enables the practitioner to change the control parameters according to the patient's needs. In addition, the practitioner can do the same program changes between control programs of a component as he/she can do by changing a colored coding plug. As it is a much faster process to change a program by the click of a button rather than to dismantle the prosthesis to gain access to the coding plug of a component, there is less disruption in the fitting process. This makes it less tiring for the patient and practitioner. As this system allows only additional adjustments to the existing adjustment possibilities by dials, there is no program change in the components, The same components which are used by the current conventional adjustment process are used with the adjustment process by CUSTOMIZING.
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