The following data is part of a premarket notification filed by Empi with the FDA for Empi Island Tens Electrode.
| Device ID | K890605 |
| 510k Number | K890605 |
| Device Name: | EMPI ISLAND TENS ELECTRODE |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-06 |
| Decision Date | 1989-03-16 |