Fond Arm Blood Pressure Monitor
Fond upper-arm monitors such as AES-U131, AES-U171 and AES-U181 determine blood pressure and pulse rate by oscillometry. An inflatable cuff transmits pressure to a transducer in the…
Fond upper-arm monitors such as AES-U131, AES-U171 and AES-U181 determine blood pressure and pulse rate by oscillometry. An inflatable cuff transmits pressure to a transducer in the monitor.
Systolic pressure, diastolic pressure and pulse rate appear on an LCD. The described models share measurement principles and structure, with differences in appearance and features.
Cuff and Model Options
The intended arm circumference is 22 to 32 cm, for users older than 12 in home or medical-facility settings. AES-U171 adds a printing function. These details apply to the named configurations within the larger monitor family.
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.
| 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
| Listed by | Alicn Medical Shenzhen, Inc, 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) | K180435 |
| Record published | 2019-04-20 |
| Record revised | 2019-11-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AES-U351 | In distribution | |
| AES-U611 | In distribution | |
| AES-U161 | In distribution | |
| AES-U121 | In distribution | |
| AES-U631 | In distribution | |
| AES-U171 | In distribution | |
| AES-U321 | In distribution | |
| AES-U131 | In distribution | |
| AES-U572 | In distribution | |
| AES-U512 | In distribution | |
| AES-U632 | In distribution | |
| AES-U181 | In distribution | |
| AES-U151 | In distribution | |
| AES-U612 | In distribution | |
| AES-U141 | In distribution | |
| AES-U522 | In distribution | |
| AES-U341 | In distribution | |
| AES-U361 | In distribution | |
| AES-U331 | In distribution | |
| AES-U311 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K231050 | 2023-10-11 |
| K230649 | 2023-09-07 |
| K221913 | 2022-10-12 |
| K212877 | 2022-01-12 |
| K210563 | 2021-10-15 |
| K180435 | 2019-01-03 |
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.