# K162407: L300 Go System

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Jan 27, 2017 after 151 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: 8 generations back to K800380 (1980). 22 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left), Bioness, Inc. (2011) Summary page 5.
- K122784: Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000; Small Ness L300 System Kit, Right, Bioness, Inc. (2012) Summary page 5.
- K140886: Walkaide System, Innovative Neurotronics, Inc. (2014) Summary page 5.

## Most influential descendants
- K173682: L300 Go System (2018), 7 descendants of its own
- 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

## Indications for use
The L300 Go System is intended to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or 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/K162407
Methodology: https://510kreport.com/methodology