510(k) clearance

YUWELL® Electronic Blood Pressure Monitor

FDA 510(k) source

510(k) number

K260670

Applicant

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Decision date

Oct 28, 2026

Date received

Mar 2, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

DXN

Device type

System, Measurement, Blood-Pressure, Non-Invasive

Device class

Class II

Regulation

21 CFR 870.1130

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Danyang, CN