Arm Blood Pressure Monitor

This automatic Arm Blood Pressure Monitor measures adult systolic and diastolic pressure and pulse rate at the upper arm. It uses a noninvasive oscillometric technique and automatically…

Registry build 21.09.26

This automatic Arm Blood Pressure Monitor measures adult systolic and diastolic pressure and pulse rate at the upper arm. It uses a noninvasive oscillometric technique and automatically inflates and deflates the cuff. Results appear in mmHg or kPa.

The monitor stores pressure, pulse and measurement time for later review, with two memory groups of 99 records. It operates from batteries or an AC power source depending on the model. A low-voltage indicator warns when the battery is running low.

Cuff and Intended Users

The subject cuff fits arm circumferences from 22 to 36 cm. Use is intended at home or in medical facilities for adults. Effectiveness has not been established in pregnant patients, including those with preeclampsia. The device is supplied nonsterile and is not intended to be sterilized by the user.

98manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DXN
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Taizhou Rich Medical Products Co., Ltd. Taizhou Jiangsu Contract manufacturer 20
Medwell Technology Limited Dongguan Guangdong Contract manufacturer 10
Honsun (Nantong) Co., Ltd. Nantong Jiangsu Contract manufacturer 9
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Yahorng Dongguan Electronic Co Ltd Guangdong Guangdong Contract manufacturer 8
Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 7
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Wuhan Strong Electronics Wuhan Hubei Contract manufacturer 6
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Shenzhen Brav Electronic Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive

Record

Regulatory record for Arm Blood Pressure Monitor
Listed by Shenzhen Hanhan Technology Co., Ltd., China
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
Establishment Manufacturer
510(k) K254225
Record published 2026-06-01

Specifications

Specifications
MRI safety MR Unsafe
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Arm Blood Pressure Monitor
Catalogue number Size Status
HH-802CB In distribution
HH-808CL In distribution
HH-812CB In distribution
HH-BP04C In distribution
HH-808EL In distribution
HH-805CB In distribution
BP-510 In distribution
HH-802EB In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Baum W.A. Baum Co., Inc. 116
Alphamed Shenzhen Urion Technology Co., Ltd. 68
Electronic Blood Pressure Monitor Shenzhen Pango Electronic Co., Ltd. 59
Arm Type Automatic Blood Pressure Monitor Shenzhen Jiacom Technology Co., Ltd. 58
A&D Medical A&D Company, Ltd. 56
Diagnostix™ American Diagnostic Corp. 54
Lutech Lutech Industries 51
Veridian Veridian Healthcare 50
Hopkins Medical Products® Hopkins Uniform Company 49
Welch Allyn, Inc. Welch Allyn, Inc. 49
Merit Medical® Argon Critical Care Systems Singapore PTE. Ltd. 48
SunTech Suntech Medical, Inc. 46

Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K254225 2026-04-01

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer