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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 the following conditions: - Relaxation of muscle spasm As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions: - Biofeedback, relaxation and muscle re-education purposes

Same as the primary predicate device, the Cionic Neural Sleeve NS-100 (K221823), the Cionic Neural Sleeve NS-200 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-200 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance. The Cionic Neural Sleeve NS-200 system sales carton consists of the following components: 1) SL-200 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in four sizes: extra-small, small, medium, and large. 2) DC-200 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-200. The DC-200 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app"). 3) Power supply and cable to recharge the DC-200 and connect the DC-200 to a user's computer when required. 4) Adhesive, electrically conductive and replaceable electrode pads. 5) Electrode cover sheets. 6) Instructions for Use documents. Components are available as accessories to the Cionic Neural Sleeve NS-200 system: - Replacement electrode pads. The Cionic Neural Sleeve NS-200 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-200 iOS and Android users. The Cionic Neural Sleeve NS-200 system consists of a software and hardware architecture that enables users to access a library exercise and programs. Programs can be added and removed from the user's mobile app by the user. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs. The following minor hardware/mechanical changes have been made to the NS-100 (K221823) and incorporate in the NS-200: 1. Simplified Sleeve Electronics By relocating the electromyography (EMG) circuitry to the Control Unit (DC-200), the redesigned Sleeve (SL-200) is now lighter, more streamlined, and requires less power—delivering a more comfortable and efficient experience for users. 2. Enhanced Control Unit Grip The Control Unit (DC-200) now features integrated side grips, making it easier to connect and disconnect from the sleeve cable—while maintaining the same compact form factor users love. 3. More Secure Fit, All Day Comfort Enhanced Velcro sections on the Sleeve (SL-200) offer improved adherence and a more secure fit, supporting confident wear and optimal electrode positioning throughout the day.