The following data is part of a premarket notification filed by Empi with the FDA for Innova Comfortpulse Vaginal Electrode (199204)/innova Comfortpulse Small Vaginal Electrode(199205).
| Device ID | K964577 |
| 510k Number | K964577 |
| Device Name: | INNOVA COMFORTPULSE VAGINAL ELECTRODE (199204)/INNOVA COMFORTPULSE SMALL VAGINAL ELECTRODE(199205) |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Contact | Carolyn M Steele Husten |
| Correspondent | Carolyn M Steele Husten EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-14 |
| Decision Date | 1997-01-24 |
| Summary: | summary |