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Pelvital USA, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories1
Latest FDA decision2024-08-01
TypeNumberDevice NameCodeDateActions
510(k) K240805 Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)HIR2024-08-01 View
510(k) K233362 Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0)HIR2023-12-29 View
510(k) K212655 FlyteHIR2021-09-21 View
510(k) K210764 FlyteHIR2021-04-13 View
510(k) K200409 Pelvital SystemHIR2020-07-10 View