Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K191179
    Device Name
    Myo Plus
    Manufacturer
    Otto Bock Healthcare Products GmbH
    Date Cleared
    2019-09-04

    (125 days)

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

    Otto Bock Healthcare Products GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.
    Device Description
    MYO PLUS measures the electromyographic control signals of the user and assigns them to the movements of the prosthesis, such as the hand or rotation unit. The product is the central control unit of a myoelectric prosthesis. By calibrating via the Myo Plus App, the control unit learns to assign muscle signals from the user to the various types of movement. This calibration can be performed by the users themselves, and repeated at regular intervals if necessary. Description of the components: Myo Plus TR The central control unit is installed in the forearm of the prosthesis and is supplied with energy by the battery system of the prosthesis. Up to 8 remote electrodes can be connected. The electronics handles the signal processing of the electrode signals and controls the compatible prosthesis components. Remote Electrode The remote electrodes take the muscle signal from the skin surface and transmit it to MyoPlus TR. The electrode contacts are located on a flexible cable and are individually screwed into the socket by the prosthesist. Myo Plus App The Myo Plus App is the central interface for the user and/or professionals to make settings on the control system or monitor operating states. The data transfer to mobile setting systems on Android or mobile iOS devices shall be carried out by a wireless connection according to the state of the art. Mvo Cuff The Myo Cuff is used to evaluate the muscle signals of a potential user of a Myo Plus controller. The Myo Cuff forms a flexible wristband which is temporarily applied to the user's forearm. Thus, the signal patterns of the user can be evaluated with the help of the app without the preparation of a complex test socket. If a user has problems separating the patterns at the beginning, he can also use the Myo Cuff for practicing with an professional. Myo Plus trial kit The Myo Plus trial kit provides the components of Myo Plus as a loaner kit for the prosthesist.
    Ask a Question
    K Number
    K141812
    Device Name
    MYGAIT STIMULATION SYSTEM
    Manufacturer
    OTTO BOCK HEALTHCARE PRODUCTS GMBH
    Date Cleared
    2015-04-02

    (269 days)

    Product Code
    GZI, IPF
    Regulation Number
    882.5810
    Why did this record match?
    Applicant Name (Manufacturer) :

    OTTO BOCK HEALTHCARE PRODUCTS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The stimulation system is intended to provide ankle dorsiflexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease. During gait, the stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.
    Device Description
    The MyGait® Stimulation System is a battery-operated two-channel stimulator and was developed exclusively for everyday use during walking in an everyday environment. The patient wears a wireless heel switch in a special sock. If the user is not able to put sufficient weight on the affected leg, he or she can wear the heel switch on the other foot. The heel switch registers heel lift and ground contact and thus the swing and stance phase. It transmits the information to the stimulator wirelessly. The stimulator is located in a cuff that holds the electrodes. It is easy to put on, even with only one hand. The correct placement of the electrodes is achieved by the cuff. The stimulator delivers the electrical stimulation to the common peroneal nerve. The nerve stimulates for controlled dorsiflexion of the foot during the swing phase. The second channel can be used independently of the first channel to provide stimulation to the knee flexors or knee extensors in patients with thigh muscle weakness. Using the wireless remote control, the patient can control and adjust the stimulator settings. When the patient sits for an extended period, the sleep mode helps save energy. The adjustment tool enables qualified personnel to adjust the stimulation parameters to the patient's individual needs. Stimulation parameters are used to affect movements in the foot. Examples of stimulation parameters are current, pulse width and shape, frequency, stimulation timing, The "MyGait Soft" PC software is used to manage and analyze gait analysis data and stimulation parameters. The data is loaded from the stimulator to the adjustment tool. The stimulation parameters can be restored to the stimulator from the PC.
    Ask a Question

    Page 1 of 1