The following data is part of a premarket notification filed by Empi with the FDA for Fes Orthosis Model No. 2000.
| Device ID | K800380 |
| 510k Number | K800380 |
| Device Name: | FES ORTHOSIS MODEL NO. 2000 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | EMPI 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-22 |
| Decision Date | 1980-03-17 |