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Modius Stress is a non-invasive, home-use neurostimulation device that is indicated to treat the symptoms of Generalized Anxiety Disorder in adults aged 22 and older, when used for approximately 4 weeks. Durability of effect after 4 weeks has not been established.

Modius Stress is a non-invasive transdermal neurostimulation device to treat the symptoms of Generalized Anxiety Disorder. The proposed mechanism of the device is through a technology known as Cranial Electrotherapy Stimulation (CES). It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1.5mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse, and adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode. The key components of the Modius Stress include the Modius Stress device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector, transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).