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The NURO Neuromodulation System (Stimulator model NURO 100) is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

The NURO Neuromodulation System is designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The NURO Neuromodulation System is a combination of the Stimulator with permanently attached single insulated lead wire, and number of single-use accessories which are sold separately, including: the acupuncture needle (provided in a single-use sterile package), needle holder, and electrode pad. The Stimulator is a small and portable pulse generator, and should only be used in conjunction with the lead wire and the single-use items listed above. The system also includes a micro USB-to-USB cable, and a USB wall charger. The Stimulator device provides treatment functions by purchasing therapy credits from a commercial website. Therapy credits are downloaded to the device through the micro-USB connection to a computer with a USB port and internet access. The Stimulator stores a record of the therapy credits purchased and available. Each therapy cycle uses a single credit. A therapy credit is required to be available on the Stimulator device in order to begin a patient treatment session. These therapy credits may be purchased with 99 as the maximum purchase. The Stimulator does not store or transfer via the USB cable any patient data. The credit transfer function is strictly a financial transaction. No patient data is stored or transferred by the Stimulator. There is no impact on safety or efficacy with purchase of therapy credits.