← Back to catalogue

Amluck Ya Horng Pc Compatible Wrist Blood Pressure Monitor, Model Ak-4000t

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040528

by Ya Horng Electronic Co., Ltd.

Identifiers

510(k) Number
K040528 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 Ya Horng PC-Compatible Wrist Blood Pressure Monitor, Model AK-4000T, is a noninvasive blood pressure measurement device designed for home use. It measures systolic and diastolic blood pressure, as well as pulse rate in adult individuals aged 18 and older. The device employs a wrist-mounted inflatable cuff to obtain readings without invasive procedures. Its classification aligns with the FDA’s Cardiovascular advisory committee under product code DXN.

This monitor is intended for single-use or reusable applications in a home setting, though sterility specifications are not detailed in the data. It is FDA 510(k) cleared under K040528, with a clearance decision dated April 15, 2004. The device is compatible with PC systems for data transfer, though no specific MRI safety or storage conditions are noted. Compliance with regulatory requirements is confirmed through the traditional 510(k) pathway.

Frequently asked questions

What is the Ya Horng AK-4000T wrist blood pressure monitor used for?

The Ya Horng AK-4000T is a noninvasive wrist-mounted device designed for home use to measure systolic and diastolic blood pressure, as well as pulse rate in adults aged 18 and older. It avoids invasive procedures by using an inflatable cuff on the wrist, making it convenient for regular monitoring.

Is the AK-4000T intended for single-use or reusable applications?

The device is specified for single-use or reusable applications in a home setting. However, the provided data does not include details about sterility requirements or cleaning instructions, so users should follow manufacturer guidelines to ensure accuracy and hygiene.

Can the AK-4000T connect to a PC for data transfer?

Yes, the Ya Horng AK-4000T is designed with PC compatibility, allowing users to transfer blood pressure readings to a computer system. This feature supports tracking and recording trends over time for better health management.

What regulatory pathway was used for FDA clearance of this device?

The AK-4000T received FDA clearance through the traditional 510(k) pathway, specifically under the Cardiovascular advisory committee (CV) and product code DXN. The device was deemed substantially equivalent to a predicate, with clearance granted on April 15, 2004.

Are there any special storage conditions or MRI safety considerations for this monitor?

The provided data does not specify any special storage conditions or MRI safety information for the Ya Horng AK-4000T. Users should store it in a clean, dry place away from direct sunlight and extreme temperatures to maintain its functionality.

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: Amluck Ya Horng Pc Compatible Wrist Blood Pressure Monitor, Model Ak ..., fda.innolitics.com, PDF APR 1 5 2004 Ya Horng CO., LTD. - Food and Drug Administration, AMLUCK YA HORNG PC… — K040528 · DeviceClearance

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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

Manufacturer

Manufacturer
Ya Horng Electronic Co., Ltd.

Sources (1)

  • FDA 510(k) K040528 24 fields · synced Oct 5, 2026