Skip to content

YUWELL Electronic Blood Pressure Monitor

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

510(k) K221372

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221372 Date17 Oct 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An electronic blood pressure monitor is a device used to measure arterial blood pressure non-invasively. This device is designed for home use and provides digital readings of systolic and diastolic pressure along with pulse rate.

The monitor is supplied with a power adapter and batteries for operation. It is intended for use in non-clinical settings such as the home. The device has received FDA 510(k) clearance under product code DXN and is classified as substantially equivalent to a predicate device.

Other devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

See all devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the YUWELL Electronic Blood Pressure Monitor used for?

    The YUWELL Electronic Blood Pressure Monitor is used to measure arterial blood pressure non-invasively, providing digital readings of systolic and diastolic pressure along with pulse rate. It is designed for home use in non-clinical settings, allowing users to track their blood pressure regularly outside of a medical facility.

  • How is the YUWELL Electronic Blood Pressure Monitor powered and supplied?

    The device is supplied with both a power adapter and batteries for operation, allowing flexible use either via AC power or battery power. This dual-power design ensures usability in various home environments, including during power outages or when mobility is needed.

  • Is the YUWELL Electronic Blood Pressure Monitor intended for clinical or home use?

    The monitor is explicitly intended for use in non-clinical settings such as the home, as stated in the device description. It is designed for personal, regular monitoring by individuals outside of hospitals or clinics, supporting self-management of blood pressure in everyday environments.

  • What regulatory clearance does the YUWELL Electronic Blood Pressure Monitor have?

    The device has received FDA 510(k) clearance under product code DXN and is classified as substantially equivalent to a predicate device. This clearance was granted via a traditional review process, confirming its safety and effectiveness for the intended use based on comparison to legally marketed devices.