Aile Fingertip Pulse Oximeter
The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate. This device is not a medical device and is not intended to diagnose…
The fingertip pulse oximeter is intended to measure the pulse oxygen saturation of arterial hemoglobin and pulse rate. This device is not a medical device and is not intended to diagnose and/or treat any medical condition or disease. This device is for Sports and Aviation use only and not for medical use.
Who Else Makes It
Concentrated in Guangdong (18), Beijing (2), Tianjin (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Shenzhen Changkun Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Hunan Accurate BIO-Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 7 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Yuezhongxing Technology Co., Ltd. | Huizhou | Guangdong | Repacker / relabeller | 10 |
| Shenzhen Creative Industry Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Shenzhen Jumper Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
Showing 12 of 29. All 29 manufacturers in China registered for Oximeter, Infrared, Sporting, Aviation
Record
| Listed by | Jiangxi Aicare Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | OCH |
| Device type | Oximeter, Infrared, Sporting, Aviation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-04-01 |
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 |
|---|---|---|
| W011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zacurate | Einstein Associates LLC | 26 |
| Contec | Contec Medical Systems Co., Ltd. | 21 |
| mibest | Beijing Choice Electronic Technology Co., Ltd. | 13 |
| Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 13 |
| Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 12 |
| Concord | Contec Medical Systems Co., Ltd. | 12 |
| Accurate® | Hunan Accurate BIO-Medical Technology Co., Ltd. | 10 |
| Acc U Rate | Health Connector LLC | 10 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 9 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 8 |
| Santamedical | Gurin Products LLC | 8 |
| Concord | Beijing Choice Electronic Technology Co., Ltd. | 8 |
Showing 12 of 100. All products under Oximeter, Infrared, Sporting, Aviation
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.