The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Metallic Fabric Electrodes.
| Device ID | K202636 |
| 510k Number | K202636 |
| Device Name: | Metallic Fabric Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Guangzhou Xinbo Electronic Co., Ltd. No.23 Building, The Second Phase, Huachuang Animation Industry Park, Panyu Guangzhou, CN 511450 |
| Contact | Sammy Li |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510006 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-11 |
| Decision Date | 2021-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970742220193 | K202636 | 000 |
| 06970742220186 | K202636 | 000 |
| 06970742220179 | K202636 | 000 |
| 06970742220162 | K202636 | 000 |