The following data is part of a premarket notification filed by Shenzhen Quality Medical Technology Co.,ltd with the FDA for Adhesive Electrodes.
| Device ID | K171381 |
| 510k Number | K171381 |
| Device Name: | Adhesive Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | ShenZhen Quality Medical Technology Co.,Ltd 5/F, Plant C3, No.1, Nuclear Power Industrial Zone Guanlan Shijing Community Shenzhen, CN |
| Contact | Grace Zhao |
| Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-11 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860074002245 | K171381 | 000 |
| 00810025923839 | K171381 | 000 |
| 00810025923822 | K171381 | 000 |
| 00850033118148 | K171381 | 000 |
| 00850033118131 | K171381 | 000 |