The following data is part of a premarket notification filed by Empi with the FDA for Empi Model 712, Logix(tm), Nms.
| Device ID | K864010 |
| 510k Number | K864010 |
| Device Name: | EMPI MODEL 712, LOGIX(TM), NMS |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Contact | Miriam J Goldberg |
| Correspondent | Miriam J Goldberg EMPI 261 SOUTH COMMERCE CIRCLE Minneapolis, MN 55432 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-15 |
| Decision Date | 1986-12-02 |