QardioArm
The FDA filing identifies QardioArm model A100 as a fully automatic, non-invasive wireless blood pressure monitor. It measures systolic and diastolic blood pressure and pulse rate in adults…
The FDA filing identifies QardioArm model A100 as a fully automatic, non-invasive wireless blood pressure monitor. It measures systolic and diastolic blood pressure and pulse rate in adults using an upper-arm cuff.
The filing says the monitor uses an oscillometric method. It also states that the device is not intended to be a diagnostic device and directs users to contact a physician if hypertensive values are indicated.
Measurement Method
The filing describes the cuff as intended for an upper arm and gives a circumference range in the device description. It also identifies wireless communication with an iPhone, iPod or iPad for this model. These are filing statements about the device and do not add clinical interpretation of its readings.
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 | Qardio, Inc., United States |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| 510(k) | K140067 |
| Record published | 2016-09-24 |
| Record revised | 2019-11-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Packaging | Masterbox of 12, pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | In distribution | |
| A100 | 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 |
|---|---|
| K220106 | 2022-06-15 |
| K140067 | 2014-06-18 |
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.