The following data is part of a premarket notification filed by Empi with the FDA for Empi, Nms/sue Cutaneous Electrode.
| Device ID | K854513 |
| 510k Number | K854513 |
| Device Name: | EMPI, NMS/SUE CUTANEOUS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Contact | George E Mathiesen |
| Correspondent | George E Mathiesen EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-12-06 |