The following data is part of a premarket notification filed by Top-rank Health Care Equipment Co., Ltd. with the FDA for Top-rank Adhesive Electrode.
| Device ID | K070612 |
| 510k Number | K070612 |
| Device Name: | TOP-RANK ADHESIVE ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. DONGGUAN ST. Shangyu City, CN 312352 |
| Contact | Uwe Degenhardt |
| Correspondent | Laura Danielson TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-05 |
| Decision Date | 2007-05-07 |