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Frequently Asked Questions
The ONWARD® Medical ARCEX® System is FDA cleared for use in the United States and CE marked in accordance with EU Medical Device Regulation 2017/745. ONWARD ARCIM® and ARCBCI™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.
*Indication for Use (US): 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 who present with a chronic, non-progressive neurological deficit resulting from an incomplete spinal cord injury (C2-C8 inclusive).
*Indication for Use (EU): The ARCEX® System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home 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).