The following data is part of a premarket notification filed by Empi with the FDA for Innova Pelvic Floor Stimulation System.
| Device ID | K941911 |
| 510k Number | K941911 |
| Device Name: | INNOVA PELVIC FLOOR STIMULATION SYSTEM |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Contact | Stacy Mattson |
| Correspondent | Stacy Mattson EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1995-01-20 |