The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Garment Electrodes.
| Device ID | K141076 |
| 510k Number | K141076 |
| Device Name: | GARMENT ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Contact | Qilian Liu |
| Correspondent | Qilian Liu SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-25 |
| Decision Date | 2014-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00311917198729 | K141076 | 000 |
| 20817915020054 | K141076 | 000 |
| 20817915020047 | K141076 | 000 |
| 00817915020036 | K141076 | 000 |