The following data is part of a premarket notification filed by Empi with the FDA for Epix Xl Tens Unit.
| Device ID | K951903 |
| 510k Number | K951903 |
| Device Name: | EPIX XL TENS UNIT |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Contact | Stacy Mattson |
| Correspondent | Stacy Mattson 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 | 1995-04-24 |
| Decision Date | 1996-03-20 |
| Summary: | summary |