The following data is part of a premarket notification filed by Empi with the FDA for Empi Logix Model 712 Nms, Tens.
| Device ID | K870168 |
| 510k Number | K870168 |
| Device Name: | EMPI LOGIX MODEL 712 NMS, TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Contact | Miriam J Goldberg |
| Correspondent | Miriam J Goldberg EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-14 |
| Decision Date | 1987-04-01 |