The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Electronic Pulse Stimulator.
| Device ID | K221992 |
| 510k Number | K221992 |
| Device Name: | Electronic Pulse Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone Shijingshan District Beijing, CN 100041 |
| Contact | Haiying Zhao |
| Correspondent | Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. No.9 Shuangyuan Road, Badachu Hi-tech Zone Shijingshan District Beijing, CN 100041 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-06 |
| Decision Date | 2022-10-21 |