K233362 is an FDA 510(k) clearance for the Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0). This device is classified as a Perineometer (Class II - Special Controls, product code HIR).
Submitted by Pelvital USA, Inc. (Eagan, US). The FDA issued a Cleared decision on December 29, 2023, 88 days after receiving the submission on October 2, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K233362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2023 |
| Decision Date | December 29, 2023 |
| Days to Decision | 88 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 |