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510(k) Data Aggregation
K Number
K192746Device Name
MyoWorx TM20
Manufacturer
Date Cleared
2021-10-19
(750 days)
Product Code
Regulation Number
890.5850Why 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.
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