# K162718: Foot Drop System (Model XFT-2001D)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xft Medical Limited
- Decided: Nov 30, 2017 after 427 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). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 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 4.

## Most influential descendants
- K193276: Nerve and Muscle Stimulator (2020), 0 descendants of its own

## Indications for use
XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Source page: https://510kreport.com/device/K162718
Methodology: https://510kreport.com/methodology