The following data is part of a premarket notification filed by Empi with the FDA for Empi Model Gls 450, Tens.
| Device ID | K861830 |
| 510k Number | K861830 |
| Device Name: | EMPI MODEL GLS 450, TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-13 |
| Decision Date | 1986-07-15 |