The following data is part of a premarket notification filed by Empi with the FDA for Innova Vaginal Emg Sensing Electrode.
| Device ID | K940091 |
| 510k Number | K940091 |
| Device Name: | INNOVA VAGINAL EMG SENSING ELECTRODE |
| Classification | Perineometer |
| Applicant | EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Contact | Stacy Mattson, Rn, Bsn |
| Correspondent | Stacy Mattson, Rn, Bsn EMPI 1275 GREY FOX RD. St Paul, MN 55112 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-07 |
| Decision Date | 1994-12-29 |