CIONIC NEURAL SLEEVE (NS-200)
CIONIC Inc.The CIONIC Neural Sleeve NS-200 is a wearable device that helps adults with foot drop and muscle weakness by electrically stimulating specific leg muscles to assist ankle and knee movements. It includes sensors to measure muscle activity, providing real-time biofeedback to guide stimulation and rehabilitation. It aims to improve gait, facilitate muscle re-education, prevent atrophy, and increase blood flow.
Intended Use
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). It electrically stimulates muscles in the affected leg and may improve gait, facilitate muscle re-education, prevent atrophy, maintain joint range of motion, and increase local blood flow.
Technology
The device consists of a fabric sleeve with embedded motion sensors and skin-contact electrodes, a portable battery-powered control unit, and a mobile application. It uses embedded surface electromyography (sEMG) sensors to measure muscle electrical activity and motion. The control unit processes these data to generate electrical stimulation to activate muscles for exercise or functional assistance. Advanced biofeedback modes include visual biofeedback and muscle-activated stimulation triggered by sEMG signals.
Performance
The CIONIC Neural Sleeve NS-200 was tested with bench testing including output waveform, isolation, hybrid stimulation, electrical safety (IEC 60601-1 series), electromagnetic compatibility (IEC 60601-1-2), muscle and nerve stimulator standards (IEC 60601-2-10), and software validation (IEC 62304). Usability testing per IEC 62366 and IEC 60601-1-6 was leveraged from predicate devices. Clinical literature supports the new indication of foot eversion stimulation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2024
4 months - 2
FDA Approval
5/2/2025
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