510(k) K193276

Nerve and Muscle Stimulator by Shenzhen Xft Medical Limited — Product Code GZI

K193276 is an FDA 510(k) premarket notification submitted by Shenzhen Xft Medical Limited for the device "Nerve and Muscle Stimulator". The FDA issued a decision of Substantially Equivalent on September 23, 2020. 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.