ViSi

ViSi Cuff Module is an accessory intended for use together with the ViSi Mobile Monitor to measure noninvasive blood pressure (NIBP) of adult patients (18 years or older).

Registry build 21.09.26
98manufacturers in China registered for this device type
14catalogue numbers in this listing

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 ViSi
Listed by Sotera Wireless, United States
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) K152341
Record published 2016-09-19
Record revised 2025-03-17 (version 10)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date, serial number
Packaging Case of 15

Catalogue Numbers

Catalogue numbers for ViSi
Catalogue number Size Per pack Status
NIBP Adapter In distribution
Disposable Adult Cuff, Large (Qty 20) 20 In distribution
ViSi Mobile Charger, 8-Bay In distribution
Disposable Wrist Cradle, Large (Qty 20) 20 In distribution
ViSi Mobile Cuff Module, Refurbished In distribution
Disposable Wrist Cradle, Medium (Qty 20) 20 In distribution
Disposable Wrist Cradle, Small (Qty 20) 20 In distribution
ViSi Mobile Charger, 2-Bay In distribution
Disposable Adult Cuff, Medium+ (Qty 20) 20 In distribution
Disposable Adult Cuff, Large+ (Qty 20) 20 In distribution
ViSi Emergency Medical Surveillance (EMS) Kit In distribution
Cuff Module In distribution
Disposable Adult Cuff, Medium (Qty 20) 20 In distribution
Disposable Adult Cuff, Small (Qty 20) 20 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

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