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510(k) Data Aggregation

    K Number
    K123399
    Device Name
    MYOVISION 3.0 WIREFREE SYSTEM
    Manufacturer
    PRECISION BIOMETRICS, INC.
    Date Cleared
    2013-08-01

    (269 days)

    Product Code
    IKN, HCC, HCS, KQX
    Regulation Number
    890.1375
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION BIOMETRICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PBI MyoVision 3G WireFree™ Systems are indicated to provide the clinician with EMG activity, skin temperature, angles of the patient's motion information during therapies that include muscle relaxation training and re-education.
    Device Description
    The MyoVision 3G WireFree™ System consists of handheld scanner devices which receive and transmit signals to a system hub. The data from the devices is displayed on a personal computer. The MyoVision 3G WireFree™ System is designed to measure and visually present physiological signals corresponding to muscle activity (surface EMG), range of motion, and maps of heat generated by the human body. This device is intended to provide the clinician with a patient's EMG activity, skin temperature, and range of motion during therapies that include muscle relaxation training and re-education. The MyoVision 3G WireFree™ System consists of four (4) physiological parameter scanners, a system hub, and proprietary application software. The four scanners are the static surface EMG scanners (ScanVision™), dynamic surface EMG scanner (DynaVision™), range of motion inclinometers (FlexVision™), and thermograph (ThermoVision™). Data collected by the scanners is wirelessly transmitted to a computer via a system hub (either SoloVision™ or PhysioMonitor™) for data processing, data storage, and visual display. The wireless feature provides for data collection efficiency and ease of use. The proprietary application software was developed and validated by Precision Biometrics, Inc. (PBI).
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