Wrist Blood Pressure Monitor W203, W202, W1681

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211041

by Shenzhen Yuezhongxing Technology Co., Ltd.

Identifiers

510(k) Number: K211041 FDA 510(k)
FDA Product Code: DXN FDA 510(k)
Models / Variants: Name:W203 FDA 510(k)EUDAMED
Wrist Blood Pressure Monitor FDA 510(k)EUDAMED
Model Name:W202 FDA 510(k)EUDAMED
Wrist Blood Pressure Monitor FDA 510(k)EUDAMED
Model Name:W1681 FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1130 FDA 510(k)
Regulation Number: 870.1130 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

This device is a Wrist Blood Pressure Monitor, classified under FDA product code DXN and intended for measuring blood pressure and pulse rate in adult patients. It operates as a digital monitor designed to provide non-invasive blood pressure readings via a wrist cuff, suitable for use in clinical and home settings.

The monitors are supplied as single-use or reusable devices (as specified by the manufacturer) and comply with FDA 510(k) clearance and MDR requirements. They are intended for wrist circumferences ranging from 5 cm (as referenced in context) and are regulated under Regulation 870.1130. No specific MRI safety or sterility details are provided in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure ..., Wrist Blood Pressure Monitor, Model Name:W203, Wrist… - FDA.report, Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K211041	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shenzhen Yuezhongxing Technology Co., Ltd.

Sources (2)

FDA 510(k) K211041 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 29, 2026