The following data is part of a premarket notification filed by Empi with the FDA for Empi, Model 1000 Hand Held Electrode.
| Device ID | K862231 |
| 510k Number | K862231 |
| Device Name: | EMPI, MODEL 1000 HAND HELD 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 | 1986-06-11 |
| Decision Date | 1986-08-27 |