The following data is part of a premarket notification filed by Renovia Inc. with the FDA for Leva Pelvic Digital Health System.
| Device ID | K192270 |
| 510k Number | K192270 |
| Device Name: | LEva Pelvic Digital Health System |
| Classification | Perineometer |
| Applicant | Renovia Inc. 263 Summer St., 5th Floor Boston, MA 02210 |
| Contact | Gina Prochilo-cawston |
| Correspondent | Gina Prochilo-cawston Renovia Inc. 263 Summer St., 5th Floor Boston, MA 02210 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002994406 | K192270 | 000 |