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Blood Pressure Monitor Model WA400 For Wrist Type And Model AA300 For Upper Arm Type

by Ningbo Diaier Electronic Co., Ltd.

510(k) K091553

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 NumberK091553 Date21 Sep 2009ClearedStatusActive

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  • Withdrawn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, 21 Sep 2026

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

The Blood Pressure Monitor, models WA400 and AA300, is a non-invasive device designed to measure systolic and diastolic blood pressure along with heart rate. It utilizes the oscillometric method to perform these measurements. The system consists of a pressure sensor, a pneumatic pump, an inflation and deflation system, an LCD display, and integrated software.

The WA400 is designed for wrist application, while the AA300 is designed for upper arm application. This device has received FDA 510k clearance. It is categorized under the cardiovascular medical specialty.

Other devices from Ningbo Diaier Electronic Co., Ltd.

Questions

AI-generated answers, 21 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 difference between the WA400 and AA300 models?

    The primary difference is the intended application site. The WA400 model is specifically designed for wrist application, while the AA300 model is designed for upper arm application.

  • What measurement method does this monitor use?

    This device utilizes the oscillometric method to determine blood pressure. It functions by using an integrated system consisting of a pressure sensor, a pneumatic pump, and an inflation and deflation system to measure systolic and diastolic pressure along with heart rate.

  • Has this device received regulatory clearance?

    Yes, the Blood Pressure Monitor models WA400 and AA300 have received FDA 510k clearance under K-number K091553. The device was reviewed by the cardiovascular advisory committee and determined to be substantially equivalent.