The following data is part of a premarket notification filed by Shenzhen Xft Medical Limited with the FDA for Foot Drop System (model Xft-2001d).
| Device ID | K162718 |
| 510k Number | K162718 |
| Device Name: | Foot Drop System (Model XFT-2001D) |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | SHENZHEN XFT Medical Limited RM 203, BLD1, 14JINHUI ROAD, NEW DISTRICT Shenzhen, CN |
| Contact | Jiang Xiaoying |
| Correspondent | Jiang Xiaoying SHENZHEN XFT Medical Limited RM 203, BLD1, 14JINHUI ROAD, NEW DISTRICT Shenzhen, CN |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2017-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970670070044 | K162718 | 000 |