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 | K211094 |
| 510k Number | K211094 |
| Device Name: | Nerve And Muscle Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Shenzhen XFT Medical Limited Room 203, Building 1, Biomedicine Innovations Industrial Park, #14 Jinhui Road Shenzhen, CN |
| Contact | Cindy Peng |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. 1713A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, CN |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-12 |
| Decision Date | 2021-07-08 |