K231780 is an FDA 510(k) clearance for the Perifit Care+. This device is classified as a Perineometer (Class II - Special Controls, product code HIR).
Submitted by X6 Innovations (Paris, FR). The FDA issued a Cleared decision on December 20, 2023, 187 days after receiving the submission on June 16, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K231780 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2023 |
| Decision Date | December 20, 2023 |
| Days to Decision | 187 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 |