Medical Device Manufacturer · US , Minneapolis , MN

Pelvital USA, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2020

Recent clearances: Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5), Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0), Flyte

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5
Cleared
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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., RQM+ and Hetrick Medical Device Consulting, LLC.

FDA 510(k) Regulatory Record - Pelvital USA, Inc.

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