Pelvital USA, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5), Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0), Flyte
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pelvital USA, Inc. Gastroenterology & Urology ✕
5 devices
Cleared
Aug 01, 2024
Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)
Gastroenterology & Urology
129d
Cleared
Dec 29, 2023
Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)
Gastroenterology & Urology
88d
Cleared
Sep 21, 2021
Flyte
Gastroenterology & Urology
29d
Cleared
Apr 13, 2021
Flyte
Gastroenterology & Urology
29d
Cleared
Jul 10, 2020
Pelvital System
Gastroenterology & Urology
142d