The following data is part of a premarket notification filed by Shenzhen Xft Medical Limited with the FDA for Nerve And Muscle Stimulator.
| Device ID | K193276 |
| 510k Number | K193276 |
| Device Name: | Nerve And Muscle Stimulator |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | Shenzhen XFT Medical Limited Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road Shenzhen, CN 518118 |
| Contact | Julia Ye |
| Correspondent | Yoyo Chen Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, CN 518100 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-09-23 |