The following data is part of a premarket notification filed by Wuxi Jiajian Medical Instrument Co., Ltd with the FDA for Jaijian Self-adhesive Electrode.
| Device ID | K192568 |
| 510k Number | K192568 |
| Device Name: | Jaijian Self-Adhesive Electrode |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-18 |
| Decision Date | 2021-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971292002519 | K192568 | 000 |
| 16971292002502 | K192568 | 000 |
| 16971292006944 | K192568 | 000 |
| 16971292006937 | K192568 | 000 |
| 16971292006883 | K192568 | 000 |
| 16971292006876 | K192568 | 000 |
| 16971292006814 | K192568 | 000 |
| 16971292006760 | K192568 | 000 |
| 16971292006753 | K192568 | 000 |