# K141812: Mygait Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Otto Bock Healthcare Products GmbH
- Decided: Apr 2, 2015 after 269 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: 7 generations back to K800380 (1980). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123972: Walkaide System, Innovative Neurotronics, Inc. (2013) Summary page 5.
- K021100: 300 PV Complete Electrotherapy System, Empi (2002) Summary page 5.
- K103343: L300 Plus System (Right, Left), L300 Plus System Upgrade Kit (Right, Left), Bioness, Inc. (2011) Summary page 5.

## Most influential descendants
- K202110: MStim Drop Model: LGT-233 (2021), 0 descendants of its own

## Indications for use
The stimulation 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 stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.

Source page: https://510kreport.com/device/K141812
Methodology: https://510kreport.com/methodology