510(k) K241634

Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) by Guangdong Xinyu Electronic and Technology Co., Ltd. — Product Code DXN

K241634 is an FDA 510(k) premarket notification submitted by Guangdong Xinyu Electronic and Technology Co., Ltd. for the device "Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)". The FDA issued a decision of Substantially Equivalent on February 11, 2025. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Guangdong Xinyu Electronic and Technology Co., Ltd. has at least 1 other 510(k) clearance on record.