# K193276: Nerve and Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xft Medical Limited
- Decided: Sep 23, 2020 after 302 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: 8 generations back to K800380 (1980). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162718: Foot Drop System (Model XFT-2001D), Shenzhen Xft Medical Limited (2017) Summary page 5.

## Indications for use
Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) 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 Nerve and Muscle Stimulator (Model: XFT-2001E, XFT-2001EA) 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 reeducation, and maintained or increased joint range of motion.

Source page: https://510kreport.com/device/K193276
Methodology: https://510kreport.com/methodology