# K122784: Ness L300 System Kit, Lef Model LG3-5100; Ness L300 System Kit, Right Model LG3-5000; Small Ness L300 System Kit, Right

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Dec 27, 2012 after 107 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.
10 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120853: Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,, Bioness, Inc. (2012) Summary page 1.
- K052329: Walkaide System, Models 20-0100, 20-0310, 20-1000, Innovative Neurotronics, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K213622: Cionic Neural Sleeve NS-100 (2022), 2 descendants of its own
- K221823: Cionic Neural Sleeve NS-100 (2022), 1 descendant of its own

## Indications for use
The NESS L300 Foot Drop System is intended to provide ankle dorsiflexion in individuals (adults and pediatrics) who have foot drop 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. The NESS L300 may improve gait, facilitate muscle re-education, prevent or retard disuse atrophy, maintain or increase joint range of motion, and increase local blood flow.

Source page: https://510kreport.com/device/K122784
Methodology: https://510kreport.com/methodology