K240805 is an FDA 510(k) clearance for the Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5), a Perineometer (Class II — Special Controls, product code HIR), submitted by Pelvital USA, Inc. (Eagan, US). The FDA issued a Cleared decision on August 1, 2024, 129 days after receiving the submission on March 25, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K240805 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2024 |
| Decision Date | August 01, 2024 |
| Days to Decision | 129 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 |