WowGoHealth Pulse Oximeter GSH601
The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for…
The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
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 | Golden Smart Home Technology Corp., Taiwan |
|---|---|
| FDA product code | OCH |
| Device type | Oximeter, Infrared, Sporting, Aviation |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-01-26 |
| Record revised | 2021-11-10 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity 15 to 80 % RH; Handling environment temperature 5 to 40 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -10 to 50 °C |
| Packaging | Box of 10, carton of 20 |
| Sizes | Weight 50 g; height 58 mm; width 34 mm; depth 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GSH601 | Weight 50 g | In distribution |
| GSH601 | Weight 50 g | 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.