The following data is part of a premarket notification filed by Guangdong Comytens Medical Technology Co., Ltd with the FDA for Self-adhesive Electrode.
| Device ID | K222453 |
| 510k Number | K222453 |
| Device Name: | Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Guangdong Comytens Medical Technology Co., Ltd Building A-102, No. 24, Jiangjunmao Industriual Zone Wulian, Longgang District Shenzhen, CN 518116 |
| Contact | Mr. Deng Jiuzhen |
| Correspondent | Mr. Amos Zou Guangdong Comytens Medical Technology Co., Ltd Building A-102, No. 24, Jiangjunmao Industrial Zone Wulian, Longgang District Shenzhen, CN 518116 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-15 |
| Decision Date | 2022-11-04 |