# K080219: Modification to:Ness L300

- Pathway: 510(k) (Special)
- Applicant: Ness-Neuromuscular Electrical Stimulation Systems
- Decided: Feb 28, 2008 after 30 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: 4 generations back to K800380 (1980). 8 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053468: NESS L300, Ness-Neuromuscular Electrical Stimulation Systems (2006) Summary page 2.

## Most influential descendants
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left) (2011), 15 descendants of its own
- 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

## Indications for use
The NESS L300 is intended to provide ankle dorsiflexion in individuals with drop foot following an upper motor neuron injury or disease. During the swing phase of gait, the NESS L300 electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot; thus, it may improve the individual's gait. The NESS L300 may also facilitate muscle re-education, prevent/retard disused atrophy, maintain or increase joint range of motion and increase local blood flow.

Source page: https://510kreport.com/device/K080219
Methodology: https://510kreport.com/methodology