The following data is part of a premarket notification filed by La Jolla Technology, Inc. with the FDA for Dynex Disposable Self-adhering Electrode W/tens.
| Device ID | K870160 |
| 510k Number | K870160 |
| Device Name: | DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS |
| Classification | Electrode, Cutaneous |
| Applicant | LA JOLLA TECHNOLOGY, INC. 11558 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Balnave, Phd |
| Correspondent | Balnave, Phd LA JOLLA TECHNOLOGY, INC. 11558 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-04-01 |