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 | K193275 |
| 510k Number | K193275 |
| 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. Room 1122#, International Mayors Communication Centre NO. 55 Shizhou Middl 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 | 2019-11-26 |
| Decision Date | 2020-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970670070228 | K193275 | 000 |