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The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm…
The Blood Pressure Monitor LS802-B is digital monitor intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 – 17 inches). This device detects the appearance of irregular heartbeats during measurement and give a warning signal with readings. The LS802-B is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. LS802-B embed a Bluetooth module that allows it to connect with nearby BT receiving terminal.
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 | Golden Smart Home Technology Corp., Taiwan |
|---|---|
| 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) | K131395 |
| Record published | 2019-04-18 |
| Record revised | 2019-11-08 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 93 % RH; Storage environment temperature -20 to 60 °C; Handling environment atmospheric pressure 80 to 105 KiloPascal; Handling environment humidity up to 85 % RH; Handling environment temperature 10 to 40 °C |
| Sizes | Height 60 mm; width 110 mm; length 138 mm |
| Distribution end date | 2019-05-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Blood Pressure Monitor LS802-B | Height 60 mm | Withdrawn |
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
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.