# K173682: L300 Go System

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Mar 9, 2018 after 98 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: 9 generations back to K800380 (1980). 23 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162407: L300 Go System, Bioness, Inc. (2017) Summary page 4.

## Most influential descendants
- K190285: L300 Go System (2019), 5 descendants of its own
- K213622: Cionic Neural Sleeve NS-100 (2022), 2 descendants of its own
- K221823: Cionic Neural Sleeve NS-100 (2022), 1 descendant of its own
- K243828: Cionic Neural Sleeve (NS-200) (2025), 0 descendants of its own
- K230997: EvoWalk 1.0 System (2023), 0 descendants of its own

## Indications for use
The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric 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 L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual’s gait. The L300 Go System 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/K173682
Methodology: https://510kreport.com/methodology