510(k) K162718

Foot Drop System (Model XFT-2001D) by Shenzhen Xft Medical Limited — Product Code GZI

K162718 is an FDA 510(k) premarket notification submitted by Shenzhen Xft Medical Limited for the device "Foot Drop System (Model XFT-2001D)". The FDA issued a decision of Substantially Equivalent on November 30, 2017. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Shenzhen Xft Medical Limited has at least 3 other 510(k) clearances on record.