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510(k) Data Aggregation

    K Number
    K143458
    Device Name
    Neurosplint
    Manufacturer
    Neurospectrum LLC
    Date Cleared
    2015-08-13

    (252 days)

    Product Code
    IQI, ILH
    Regulation Number
    890.3475
    Why did this record match?
    Product Code :

    IQI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An orthosis worn on the wrist With rigid insert: to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist Without rigid insert: - . to provide wrist support - . to provide temporary relief of associated symptoms of some repetitive motion wrist conditions - to provide feedback to the user when the wrist reaches maximal flexion or extension
    Device Description
    An orthosis worn on the wrist
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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?
    Product Code :

    IQI

    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
    K031576
    Device Name
    SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
    Manufacturer
    SURGITECH, INC.
    Date Cleared
    2003-07-31

    (72 days)

    Product Code
    IQI
    Regulation Number
    890.3475
    Why did this record match?
    Product Code :

    IQI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An orthosis worn on the wrist for medical purposes: - to support and/or immobilize for functional improvement. - for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist. - to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries. - to provide temporary relief of associated symptoms of some wrist conditions.
    Device Description
    Not Found
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