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The Ouell-FM is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Quell-FM may be used during sleep. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes.

Ouell-FM is a wearable, transcutaneous electrical nerve stimulator designed to stimulate sensory nerves in the upper-calf region. The device utilizes a microprocessor running embedded software and a custom high-voltage Application Specific Integrated Circuit (ASIC) to generate current regulated stimulating pulses with specific characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device utilizes Bluetooth® low energy (BLE) to communicate with a mobile device that allows the user to start and stop therapy, control stimulation intensity, and modify certain operating characteristics. The device is powered by an embedded rechargeable lithium-ion polymer battery that is charged through a USB cable connected to an AC adapter. The primary components of the device include the Quell-FM device, Band, Electrodes, and Quell-FM mobile app. - A. Quell-FM Device The Quell-FM device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes (previously cleared in K140586), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. - B. Band A flexible band secures the Quell-FM device and the electrode to the user's leg using a hook and loop material. - C. Electrodes The Quell-FM device is labeled for use only with compatible NeuroMetrix electrodes (i.e., electrodes cleared under K140586). This use specification, in part, ensures the safe use of the device during sleep because NeuroMetrix electrodes have a known surface area that allows the device to quantitively determine relative skin contact area. Stimulation will be automatically stopped if device detects a decrease in skin-contact area which may lead to unsafe current density to be delivered as would occur during unattended use such as sleeping. - D. Quell-FM Mobile App Quell-FM is used with a mobile app, running on an iOS or Android mobile device, to which it communicates via Bluetooth. Using the mobile app, the user can start and stop the therapy, control stimulation intensity, and modify certain operating characteristics.