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The ARCEX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).

The ARCES System is a medical device that delivers transcutaneous programmed. Carrier Frequency-enabled electrical spinal cord stimulation (ARCEN Therapy). The System is intended to be used in conjunction with functional task practice in the clinic to improve hand sensation and strength in individuals with cervical spinal cord injury (SCI). The stimulation is intended to be delivered transcutaneously and the active electrodes are intended to be placed in direct contact with intact skin, in appropriate locations along or near the spine to elicit desired outcomes. The ARCES System is intended to be used in a medical center setting by patients and their rehabilitation professionals. The primary components of the ARCEX System are: ARCEX Stimulator, ARCEX Stimulator Charger, ARCEX Splitter Box, ARCEX Extension Cables, ARCEX Programmer, Programmer Charger, and ARCEX Case. The ARCES System is intended to be used with the FDA-cleared Axelgaard PALS electrodes (K132422).