K180637 is an FDA 510(k) clearance for the leva Pelvic Floor Trainer. 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 April 4, 2018, 23 days after receiving the submission on March 12, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K180637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2018 |
| Decision Date | April 04, 2018 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | HIR - Perineometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1425 |