The following data is part of a premarket notification filed by Top-rank Health Care Equipment Co., Ltd. with the FDA for Adhesive Electrodes.
| Device ID | K132588 |
| 510k Number | K132588 |
| Device Name: | ADHESIVE ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-19 |
| Decision Date | 2013-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816924020697 | K132588 | 000 |
| 05033435138784 | K132588 | 000 |
| 05033435139118 | K132588 | 000 |
| 05033435139132 | K132588 | 000 |
| 05033435139156 | K132588 | 000 |
| 10810038636129 | K132588 | 000 |
| 05060217493588 | K132588 | 000 |
| 00810038630038 | K132588 | 000 |
| 00810038630052 | K132588 | 000 |
| 00850253007161 | K132588 | 000 |
| 00850253007178 | K132588 | 000 |
| 10850253007786 | K132588 | 000 |
| 00858058005030 | K132588 | 000 |
| 20816924020680 | K132588 | 000 |
| 05033435138777 | K132588 | 000 |