The following data is part of a premarket notification filed by Remendium Labs, Llc with the FDA for Ieva Rehabilitative Positional Device.
| Device ID | K133990 |
| 510k Number | K133990 |
| Device Name: | IEVA REHABILITATIVE POSITIONAL DEVICE |
| Classification | Perineometer |
| Applicant | REMENDIUM LABS, LLC 340 EAST PARKER ROAD Baton Rouge, LA 70803 |
| Contact | Yolanda Lorie |
| Correspondent | Yolanda Lorie REMENDIUM LABS, LLC 340 EAST PARKER ROAD Baton Rouge, LA 70803 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-27 |
| Decision Date | 2014-10-09 |
| Summary: | summary |