The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd with the FDA for Transcutaneous Electrical Nerve Stimulator.
| Device ID | K202893 |
| 510k Number | K202893 |
| Device Name: | Transcutaneous Electrical Nerve Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, CN 214116 |
| Contact | Caihong Sun |
| Correspondent | Caihong Sun Wuxi Jiajian Medical Instrument Co., Ltd No. 35 Baiqiao Rd., Ehu Town, Xishan District, Wuxi, CN 214116 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-28 |
| Decision Date | 2021-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932307410432 | K202893 | 000 |