The following data is part of a premarket notification filed by Shenzhen Mailuokang Technology Co., Ltd. with the FDA for Mailuokang Self-adhesive Electrode.
| Device ID | K152815 |
| 510k Number | K152815 |
| Device Name: | Mailuokang Self-adhesive Electrode |
| Classification | Electrode, Cutaneous |
| Applicant | SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD. RM 602, 6/F, BUILDING B, NANCHANG JIANYU NO. 2 INDUSTRIAL ZONE, GUSHU VILLAGE Shenzhen, CN 518000 |
| Contact | Hu Pandeng |
| Correspondent | Elena Lu SHENZHEN JOYANTECH CONSULTING CO., LTD. ROOM 2032, INTERNATIONAL MAYORS COMMUNICATION CENTRE Shenzhen, CN 518000 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-28 |
| Decision Date | 2016-03-08 |
| Summary: | summary |