The following data is part of a premarket notification filed by Jiangsu Zekang Medical Technology Co., Ltd with the FDA for Zekang Self-adhesive Electrode.
| Device ID | K150971 |
| 510k Number | K150971 |
| Device Name: | Zekang Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | Jiangsu Zekang Medical Technology Co., Ltd Building 22, Wuxi Zhongguancun Software Park Wuxi, CN 214135 |
| Contact | Doris Dong |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd Room 1706, No. 128 Songle Rd., Songjiang Area Shanghai, CN 201600 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-13 |
| Decision Date | 2015-08-25 |
| Summary: | summary |