# K243828: Cionic Neural Sleeve (NS-200)

- Pathway: 510(k) (Traditional)
- Applicant: Cionic, Inc.
- Decided: May 2, 2025 after 140 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K800380 (1980). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221823: Cionic Neural Sleeve NS-100, Cionic (2022) Summary page 5.
- K080950: Stiwell MED4, Otto Bock, Austria GmbH (2009) Summary page 5.

## Indications for 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). 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

Source page: https://510kreport.com/device/K243828
Methodology: https://510kreport.com/methodology