Mesi mTABLET ABI

The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform,…

Registry build 21.09.26

The MESI mTABLET ABI is an automated wireless ankle-brachial index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, viewing and storing ankle-brachial index (ABI) measurement of adult patients → patients in the PAD risk group. It is a wireless system which is comprised of a wireless medical tablet system, four tubeless blood pressure cuff modules and a 4-port charging station module.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code JOM
Manufacturer City Province Registered as Device types
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Shenzhen Raycome Health Technology Co., Ltd. Shenzhen Guangdong Manufacturer 3

Record

Regulatory record for Mesi mTABLET ABI
Listed by Mesi D.O.O., Slovenia
FDA product code JOM
Device type Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device class Class 2
Regulation 21 CFR 870.2780
Establishment Manufacturer
510(k) K201046
Record published 2021-07-09

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for Mesi mTABLET ABI
Catalogue number Size Status
MTABSYSABI In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dopplex Huntleigh Healthcare Ltd. 16
Hokanson D. E. Hokanson, Inc. 7
Medi Medi Manufacturing Inc 6
QuantaFlo Semler Scientific, Inc. 5
FloChec Semler Scientific, Inc. 3
Doppler Model 1059-C W/PPG Parks Medical Electronics, Inc. 2
TBL-ABI LD Technology LLC 1
SA-3000P Medicore Co., Ltd. 1
Doppler Model 1050-C W/PPG Parks Medical Electronics, Inc. 1
Doppler Model 1058-C W/PPG Parks Medical Electronics, Inc. 1
Max Pulse Medicore Co., Ltd. 1
Doppler Model 1052-C Parks Medical Electronics, Inc. 1

Showing 12 of 20. All products under Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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