Shenzhen Urion Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T), Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).), Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Urion Technology Co., Ltd. Cardiovascular ✕
6 devices
Cleared
May 14, 2026
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M,...
Cardiovascular
148d
Cleared
Mar 26, 2026
Automatic Electronic Blood Pressure Monitor (U90B series models including (...
Cardiovascular
56d
Cleared
Feb 21, 2025
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including...
Cardiovascular
144d
Cleared
Oct 24, 2024
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
Cardiovascular
195d
Cleared
Apr 22, 2016
U80 Series Upper Arm Electronic Blood Pressure Monitor
Cardiovascular
108d
Cleared
Apr 03, 2015
ELECTRONIC BLOOD PRESSURE MONITOR
Cardiovascular
284d