K192270 is an FDA 510(k) clearance for the LEva Pelvic Digital Health System. This device is classified as a Perineometer (Class II - Special Controls, product code HIR).
Submitted by Renovia, Inc. (Boston, US). The FDA issued a Cleared decision on November 22, 2019, 92 days after receiving the submission on August 22, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K192270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIR — Perineometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1425 |