# K191587: L360 Thigh System

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: Sep 12, 2019 after 90 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: 11 generations back to K800380 (1980). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190285: L300 Go System, Bioness, Inc. (2019) Summary page 5.
- K110350: Kneehab XP, Bio-Medical Research, Ltd. (2011) Summary page 5.

## Indications for use
The L360 Thigh System is intended to 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 L360 Thigh System electrically stimulates muscles in the affected leg to provide knee flexion or extension; thus, it also may improve the individual’s gait. The L360 Thigh System may also: • Facilitate muscle re-education • Prevent/retard disuse atrophy • Maintain or increase joint range of motion • Increase local blood flow • Provide early post-surgical quadricep and hamstring strengthening • Improve post-surgical knee stability secondary to quadricep and hamstring strengthening • Relax muscle spasms

Source page: https://510kreport.com/device/K191587
Methodology: https://510kreport.com/methodology