MOCACuff

MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist.…

Registry build 21.09.26

MOCACuff (HL168KF) uses the oscillometric method to automatically measure systolic and diastolic blood pressure as well as heart rate. The measurement position is at human being’s wrist. All values can be read out in one LD panel. The device is designed for home use and recommended for use by adults aged 18 years and older with wrist circumference ranging approx. 5.3~7.7 inch. The user is able to set the personal target value and the device will flash the value when the measured blood pressure value exceeds the target one. Further, HL168KF feature a built-in Bluetooth Data Transmission function, which enables the device automatically transmit measuring results to paired Bluetooth device after measurement.

98manufacturers in China registered for this device type
2catalogue 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 MOCACuff
Listed by Mocacare Corp.
FDA product code DXN
Device type System, Measurement, Blood-Pressure, Non-Invasive
Device class Class 2
Regulation 21 CFR 870.1130
Record published 2016-12-09
Record revised 2023-08-14 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries serial number
Storage Storage environment humidity up to 93 % RH; Storage environment temperature -13 to 158 °F; Handling environment temperature 41 to 104 °F; Handling environment humidity 15 to 93 % RH; Handling environment atmospheric pressure 700 to 1060 millibar

Catalogue Numbers

Catalogue numbers for MOCACuff
Catalogue number Size Status
HL168KF In distribution
White (HL168KF) 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