Mesi mTABLET TBI
The MESI mTABLET TBI is an automated wireless Toe-Brachial Index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, view,…
The MESI mTABLET TBI is an automated wireless Toe-Brachial Index measuring system for screening patients for Peripheral Arterial Disease (PAD/LEAD). The system is intended to perform, view, and store toe-brachial index (TBI) measurements of adult patients – patients in the PAD risk group – especially diabetic, renal, and elder patients who may suffer from calcified vessels. It is a wireless system that is comprised of a wireless medical tablet system, a toe blood pressure module, two tubeless blood pressure cuff modules, and a 4-port charging station module. MESI mTABLET TBI is intended to be used in a professional clinical environment by trained healthcare personnel who understand the principle of toe-brachial index (TBI) measurement and are able to place arm cuffs, digit cuffs and photoplethysmographic (PPG) probes on the patient body, as well as able to verify that these accessories are working as intended and to start the measurement process.
Who Else Makes It
All of them in Guangdong.
| 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
| 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) | K213730 |
| Record published | 2022-04-25 |
| Record revised | 2023-11-22 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MTABSYSTBI | In distribution |
Same 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 |
| Mesi mTABLET ABI | Mesi D.O.O. | 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 |
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.