The following data is part of a premarket notification filed by Empi with the FDA for Innova Rectal Stimulaton Electrode.
| Device ID | K954272 |
| 510k Number | K954272 |
| Device Name: | INNOVA RECTAL STIMULATON ELECTRODE |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | EMPI 5255 EAST RIVER RD. Minneapolis, MN 55421 |
| Contact | Stacy Mattson |
| Correspondent | Stacy Mattson EMPI 5255 EAST RIVER RD. Minneapolis, MN 55421 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-12 |
| Decision Date | 1996-04-15 |
| Summary: | summary |