Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192746
    Device Name
    MyoWorx TM20
    Manufacturer
    Date Cleared
    2021-10-19

    (750 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    MyoWorx Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Muscle relaxation and increased local blood circulation.
    Device Description
    The TM20 is a device used for muscle relaxation. It sends biphasic pulses to targeted distressed muscles, and by delivering a specified sequence of timed and abrupt electrical frequency pulses, the device can be used to decrease the tension of the muscle fibers and leads to greater blood flow. The user operates the device by means of a keypad overlay. The overlay allows for the user to adjust the treatment length, adjust intensity of each stimulation output, adjust maximum power of stimulation, and start, pause, and stop treatment. The values being set and current stage of treatment is displayed to the user by means of an LCD display, alpha numeric displays, and LEDs. The TM20 device consists of the following: 1. User Interface Overlay 2. External Power Supply for TM20 3. A main board for controlling and monitoring the generated output 4. 10 Individual output channels, and a stimulation circuit for each channel 5. Communication and stimulation cables 6. A custom bent metal enclosure.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1