The following data is part of a premarket notification filed by Hong Qiangxing (shen Zhen) Electronics Limited with the FDA for Sm Electrodes.
| Device ID | K183154 |
| 510k Number | K183154 |
| Device Name: | SM Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Hong Qiangxing (Shen Zhen) Electronics Limited 4F, Jingcheng Building, Xicheng Industrial Zone Xixiang Road, Bao'an District Shenzhen, CN 518126 |
| Contact | Xu Jianhua |
| 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 | 2018-11-14 |
| Decision Date | 2019-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810041987577 | K183154 | 000 |
| 10810041987560 | K183154 | 000 |
| 10810041987522 | K183154 | 000 |
| 10810041987515 | K183154 | 000 |
| 10810041987508 | K183154 | 000 |