BioStep vs Neural Study

The BioStep app is a professional ordering tool that allows licensed healthcare providers to capture 3D foot scans and submit orders for custom foot orthotics and AFOs fabricated by BioStep Inc. Providers can customize orders with complete product descriptions and images of every product. This app is intended exclusively for use by licensed healthcare professionals, including Podiatrists, Orthotists, Prosthetists, and Chiropractors. It is not intended for patient self-use and does not provide diagnoses, health measurements, or treatment advice. All clinical specifications are determined and entered by the treating provider. BioStep custom foot orthotics and AFOs are Class I devices, exempt from FDA premarket notification under 21 CFR 890.3475, and are intended for distribution within the United States. Disclaimer: This app is a professional ordering tool and is not a substitute for professional medical judgment. Patients should always seek the advice of a physician or qualified healthcare provider regarding any medical condition and before making any medical decisions. Note: A User Name and Password issued by BioStep is required to access the app.

****THIS APPLICATION IS FOR CLINICIANS AND PARTICIPANTS ENROLLED IN AN ACTIVE CIONIC-SPONSORED CLINICAL RESEARCH STUDY. IT IS NOT INTENDED FOR GENERAL PUBLIC USE.**** Neural Study is the companion app for the Cionic Neural Sleeve (NS-100 and NS-200), used to run clinical research studies of the Sleeve's functional electrical stimulation technology. FOR CLINICIANS AND STUDY STAFF - Configure and pair Neural Sleeve devices for enrolled participants - Set and adjust stimulation programs per study protocol - Assign training programs for participants to complete - Monitor device status, battery, and connection in real time - Review session and usage data ahead of study visits FOR STUDY PARTICIPANTS - Connect to your assigned Neural Sleeve - Start and stop sessions as directed by your study team - View and complete training programs assigned by your clinician - View your session history - Stay in sync with your study team between visits Neural Study is provided as part of an IRB-approved research study. Access requires enrollment and credentials issued by your study site. The Cionic Neural Sleeve is available by prescription only. FDA-CLEARED INDICATIONS FOR USE Cionic Neural Sleeve NS-200 (K243828) The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-200 may also: - Facilitate muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow As a powered muscle stimulator, the Cionic Neural Sleeve NS-200 is indicated for: - Relaxation of muscle spasm As a biofeedback device, the Cionic Neural Sleeve NS-200 is indicated for: - Biofeedback, relaxation and muscle re-education purposes Cionic Neural Sleeve NS-100 (K221823) The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-100 may also: - Facilitate muscle re-education - Prevent/retard disuse atrophy - Maintain or increase joint range of motion - Increase local blood flow See the Instructions for Use provided with your device for complete indications, contraindications, warnings, and precautions. Questions about the app or your study? Contact your study coordinator, or reach us at https://cionic.com/contact.