The following data is part of a premarket notification filed by La Jolla Technology, Inc. with the FDA for Dynex Iii Transcutaneous Electrical Nerve Stimula..
| Device ID | K864956 |
| 510k Number | K864956 |
| Device Name: | DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LA JOLLA TECHNOLOGY, INC. 11558 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Balnave, Ph.d. |
| Correspondent | Balnave, Ph.d. LA JOLLA TECHNOLOGY, INC. 11558 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-18 |
| Decision Date | 1987-03-09 |