The following data is part of a premarket notification filed by Electrode Market Co.,ltd. with the FDA for Electrode Market Disposable Surface Electrodes.
| Device ID | K211839 |
| 510k Number | K211839 |
| Device Name: | Electrode Market Disposable Surface Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Electrode Market Co.,Ltd. 205, Manhae-ro, Danwon-gu, A-dong 717 Ho Ansan-si, KR 15421 |
| Contact | Seolmin Jeong |
| Correspondent | Seolmin Jeong Electrode Market Co.,Ltd. 205, Manhae-ro, Danwon-gu, A-dong 717 Ho Ansan-si, KR 15421 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-14 |
| Decision Date | 2021-07-28 |