The following data is part of a premarket notification filed by Bozhou Rongjian Medical Appliance Co.,ltd. with the FDA for Self-adhesive Electrode.
| Device ID | K213879 |
| 510k Number | K213879 |
| Device Name: | Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, CN 233500 |
| Contact | Zhifang Wu |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-01-05 |