The following data is part of a premarket notification filed by Shenzhen Future Electronic Co., Ltd with the FDA for Transcutaneous Electrical Nerve Stimulator Model: St-304.
| Device ID | K221092 |
| 510k Number | K221092 |
| Device Name: | Transcutaneous Electrical Nerve Stimulator Model: ST-304 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Future Electronic Co., Ltd Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang District Shenzhen, CN 518116 |
| Contact | Zhao Qihong |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K, NO. 101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-13 |
| Decision Date | 2022-09-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06959557200354 | K221092 | 000 |
| 05060823620293 | K221092 | 000 |