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ClearUP Sinus Relief device is a transcutaneous electrical nerve stimulator that electrically stimulates the skin overlying the paranasal sinuses and is intended to be used for the temporary relief of moderate to severe congestion. ClearUP Sinus Relief is a treatment to be used at home by individuals 18 and older.

ClearUP Sinus Relief is an over-the-counter, handheld microcurrent stimulation reusable device to be used at home by individuals 18 and older with moderate to severe congestion (Figure 1). Note that Tivic Health Systems Inc. received a 510(k) clearance (K182025) for a similar device, ClearUp Sinus Pain Relief, for the temporary relief of sinus pain associated with Allergic Rhinitis. In the current De Novo, Tivic Health Systems made minor design changes to the device, intended to be used for the temporary relief of moderate to severe congestion. The unit applies microcurrent waves at a very low level of electrical current to the skin overlying the paranasal sinuses and continuously measures skin impedance as the user glides the electrode along the skin. When the skin impedance measurement drops below a threshold, ClearUP Sinus Relief identifies this as a treatment point in the skin overlying the paranasal sinuses which allows current to pass most easily across the skin. The device indicates a treatment point with a brief haptic vibration. These low-impedance points correlate with subcutaneous nerve fibers and foramina (holes) through which major nerve fibers pass from the sinus passages, through the skull, to areas near the skin (Figure 2). The pear-shaped device is held in the hand, with the rounded tip of the device applied to the facial skin in the region of the paranasal sinuses. The tip is the active electrode of a monopolar design. The housing of the device serves as the return electrode. The hand holding the device completes the electrical path. Once the haptic vibration ends, the user is instructed to glide the device along the indicated path until reaching the next low-impedance area, at which point the haptic vibration will activate again. A single treatment is 5 minutes in duration. The user may adjust the current setting of the device (low, medium, high) if they prefer more or less current intensity. The default setting for the device is low. The device is reusable for a single user, provided non-sterile, and it is not required to be sterilized prior to use.