510(k) K162718

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2017
Date Received
September 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type