The following data is part of a premarket notification filed by Fx-2 with the FDA for Fx-4 Nms (4channel Table Model).
| Device ID | K945510 |
| 510k Number | K945510 |
| Device Name: | FX-4 NMS (4CHANNEL TABLE MODEL) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | FX-2 616 VINEYARD PT. Guilford, CT 06437 |
| Contact | Mark Heller |
| Correspondent | Mark Heller FX-2 616 VINEYARD PT. Guilford, CT 06437 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-05-02 |