K162718 is an FDA 510(k) clearance for the Foot Drop System (Model XFT-2001D). This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Shenzhen Xft Medical Limited (Shenzhen, CN). The FDA issued a Cleared decision on November 30, 2017, 427 days after receiving the submission on September 29, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K162718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2016 |
| Decision Date | November 30, 2017 |
| Days to Decision | 427 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZI - Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |