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Digital Blood Pressure Monitor WBP Series (WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210671

by Weony (shenzhen) Technology Co., Ltd.

Identifiers

510(k) Number
K210671 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

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)

The Digital Blood Pressure Monitor WBP Series (WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107) is an automated sphygmomanometer designed for measuring systolic and diastolic blood pressure. It utilises oscillometric technology to provide accurate readings, suitable for clinical and home monitoring applications.

These devices are intended for single-use or reusable settings, depending on the model variant, and are regulated under FDA 510(k) clearance and the Medical Device Directive (MDD). Each model in the series is assigned a unique reference code and adheres to cardiovascular advisory committee standards, ensuring compliance with traditional clearance pathways. Storage and handling instructions are specified per model to maintain device integrity and performance.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Weony (shenzhen) Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K210671 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026