The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 989, Tens.
| Device ID | K881114 |
| 510k Number | K881114 |
| Device Name: | EMPI MODEL 989, TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Contact | E Mathiesen |
| Correspondent | E Mathiesen EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-15 |
| Decision Date | 1988-04-15 |