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510(k) Data Aggregation

    K Number
    K233006
    Device Name
    MyndMove, MyndMove 2.0
    Manufacturer
    MyndTec Inc.
    Date Cleared
    2024-06-25

    (277 days)

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

    MyndTec Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses: Functional electrical stimulation (FES) Improvement of arm and hand function and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for: - · maintenance and/or increase of arm and hand range of motion, - · prevention and/or retardation of disuse atrophy, - · increase in local blood circulation, - · reduction in muscle spasm, and - · re-education of muscles. MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.
    Device Description
    The MyndMove and MyndMove 2.0 Systems are neuromodulation devices that deliver short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove and MyndMove 2.0 systems comprise the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The Functional Electrical Stimulators in the MyndMove 2.0 are eight-channel devices with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided. Each MyndMove/MyndMove 2.0 Stimulator is connected, via an IEEE 802.11 a/b/g/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove 2.0 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove and MyndMove 2.0 use surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand. MyndMove and MyndMove 2.0 are based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove or MyndMove 2.0 protocols achieve a wide range of functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the MyndMove/MyndMove 2,0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting a movement. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.
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    K Number
    K212149
    Device Name
    MyndMove 2.0
    Manufacturer
    MyndTec Inc.
    Date Cleared
    2022-03-03

    (237 days)

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

    MyndTec Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MYNDMOVE is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) Improvement of ann and hand functions and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) · Maintenance and/or increase of arm and hand range of motion - · Prevention and/or retardation of disuse atrophy - · Increase in local blood circulation - · Reduction of muscle spasm · Re-education of muscles. Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.
    Device Description
    The MyndMove 2.0 System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove 2.0 Functional Electrical Stimulator is an eight-channel device with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided. Each MyndMove Stimulator is connected, via an IEEE 802.11 a/b/q/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove 2.0 Therapy can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove system. MyndMove 2.0 uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand. MyndMove 2.0 is based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove 2.0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting move and as the arm and/or hand is moved into the instructed position. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.
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