Pelvital USA, Inc. - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Pelvital USA, Inc. has 5 FDA 510(k) cleared medical devices. Based in Minneapolis, US.
Latest FDA clearance: Aug 2024. Active since 2020. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Pelvital USA, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Winegar Consulting, Inc. and RQM+.
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