# K221823: Cionic Neural Sleeve NS-100

- Pathway: 510(k) (Special)
- Applicant: Cionic
- Decided: Jul 21, 2022 after 28 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: 12 generations back to K800380 (1980). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213622: Cionic Neural Sleeve NS-100, Cionic (2022) Summary page 5.

## Most influential descendants
- K243828: Cionic Neural Sleeve (NS-200) (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K221823
Methodology: https://510kreport.com/methodology