# K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left)

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Apr 29, 2011 after 165 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: 5 generations back to K800380 (1980). 15 ancestors in all.
15 later devices descend from it; 3 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)
- K080219: Modification to:Ness L300, Ness-Neuromuscular Electrical Stimulation Systems (2008) Summary page 3.
- K022776: Ness System, Ness-Neuromuscular Electrical Stimulation Systems (2002) Summary page 3.

## Most influential descendants
- K123972: Walkaide System (2013), 14 descendants of its own
- K140886: Walkaide System (2014), 10 descendants of its own
- K162407: L300 Go System (2017), 9 descendants of its own
- K173682: L300 Go System (2018), 7 descendants of its own
- K190285: L300 Go System (2019), 5 descendants of its own

## Indications for use
The NESS L300 Plus System is intended to Provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease. During gait, the L300 Plus System electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot and knee flexion or extension, thus it may improve the individual's gait. The L300 Plus 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/K103343
Methodology: https://510kreport.com/methodology