The following data is part of a premarket notification filed by Western Advanced Technology, Inc. with the FDA for Tens Device.
| Device ID | K812138 |
| 510k Number | K812138 |
| Device Name: | TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | WESTERN ADVANCED TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-28 |
| Decision Date | 1981-08-20 |