Digital Automatic Wrist Blood Pressure Monitor WBPM15 Series

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120673

by Grandway Technology (shenzhen) Limited

Identifiers

510(k) Number: K120673 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 Automatic Wrist Blood Pressure Monitor Wbpm15 Series is a device used to measure blood pressure. It is an automatic wrist blood pressure monitor, providing a digital display of the measurement results.

The device is supplied by Grandway Technology (Shenzhen) Limited and has been authorized with FDA 510K clearance. It is classified under the product code DXN and has been reviewed by the Cardiovascular advisory committee. The device is available with the model number Wbpm15 Series.

Frequently asked questions

What is the Wbpm15 Series used for?

The Wbpm15 Series is used to measure blood pressure, providing a digital display of the measurement results.

Is the Wbpm15 Series authorized by regulatory bodies?

Yes, the Wbpm15 Series has been authorized with FDA 510K clearance, indicating it has been reviewed and found substantially equivalent.

What is the product code for the Wbpm15 Series?

The Wbpm15 Series is classified under the product code DXN, which is a classification for devices related to cardiovascular health.

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 (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K120673	Class II	Active

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Manufacturer

Manufacturer: Grandway Technology (shenzhen) Limited

Sources (1)

FDA 510(k) K120673 24 fields · synced Oct 6, 2026