K212495 is an FDA 510(k) clearance for the Leva Pelvic 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 September 8, 2021, 30 days after receiving the submission on August 9, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K212495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2021 |
| Decision Date | September 08, 2021 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | HIR — Perineometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1425 |