The following data is part of a premarket notification filed by Cathay International, Ltd. with the FDA for Sof-pach Reusable Neurostimulation Electrodes.
| Device ID | K020735 |
| 510k Number | K020735 |
| Device Name: | SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES |
| Classification | Electrode, Cutaneous |
| Applicant | CATHAY INTERNATIONAL, LTD. RM. 8F-3, NO. 29, CHUNGSHAN N. RD. SEC 3 Taipei, TW |
| Contact | Anne Jen |
| Correspondent | Anne Jen CATHAY INTERNATIONAL, LTD. RM. 8F-3, NO. 29, CHUNGSHAN N. RD. SEC 3 Taipei, TW |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-06 |
| Decision Date | 2002-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06959006302837 | K020735 | 000 |
| 06959006302783 | K020735 | 000 |
| 06959006302752 | K020735 | 000 |
| 06959006302646 | K020735 | 000 |
| 06959006302332 | K020735 | 000 |
| 06959006302226 | K020735 | 000 |
| 06959006302172 | K020735 | 000 |
| 06959006302073 | K020735 | 000 |
| 06959006302066 | K020735 | 000 |