Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Shenzhen Urion Technology Co., Ltd.

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories3
Latest FDA decision2026-05-14
TypeNumberDevice NameCodeDateActions
510(k) K254048 Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)DXN2026-05-14 View
510(k) K260273 Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)DXN2026-03-26 View
510(k) K250046 Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)IRP2025-04-25 View
510(k) K243115 Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))DXN2025-02-21 View
510(k) K241007 Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)DXN2024-10-24 View
510(k) K200802 Infrared ThermometerFLL2020-10-07 View
510(k) K160019 U80 Series Upper Arm Electronic Blood Pressure MonitorDXN2016-04-22 View
↑