The following data is part of a premarket notification filed by Voncare Medical Device Co., Ltd with the FDA for Adhesive Electrodes.
| Device ID | K212191 |
| 510k Number | K212191 |
| Device Name: | Adhesive Electrodes |
| Classification | Electrode, Cutaneous |
| Applicant | Voncare Medical Device Co., Ltd Shiwan Science And Technology Industrial Park, Yongshi Avenue East Boluo County, Huizhou, CN 516127 |
| Contact | Jimmy Zhai |
| Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-12 |
| Decision Date | 2021-10-06 |