# K053468: NESS L300

- Pathway: 510(k) (Traditional)
- Applicant: Ness-Neuromuscular Electrical Stimulation Systems
- Decided: Jul 7, 2006 after 206 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: 3 generations back to K800380 (1980). 7 ancestors in all.
17 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)
- K050991: The Odfs Dropped Foot Stimulator, Department of Medical Physics and Biomedical Eng. (2005) Summary page 3.
- K974514: External Functional Neuromuscular Stimulator, Neuromotion, Inc. (1998) Summary page 3.

## Most influential descendants
- K080219: Modification to:Ness L300 (2008), 16 descendants of its own
- 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

## 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 disuse atrophy, maintain or increase joint range of motion and increase local blood flow.

Source page: https://510kreport.com/device/K053468
Methodology: https://510kreport.com/methodology