The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 984 Basix, Tens.
| Device ID | K841045 |
| 510k Number | K841045 |
| Device Name: | EMPI MODEL 984 BASIX, TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 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 | 1984-03-12 |
| Decision Date | 1984-04-13 |