510(k) K221040

Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) by Jiangxi Aicare Medical Technology Co., Ltd. — Product Code DXN

K221040 is an FDA 510(k) premarket notification submitted by Jiangxi Aicare Medical Technology Co., Ltd. for the device "Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)". The FDA issued a decision of Substantially Equivalent on August 31, 2022. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Jiangxi Aicare Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.