Data / Medical devices / China / Dongguan Kangweile Electronic Technology Co., Ltd
Dongguan Kangweile Electronic Technology Co., Ltd: FDA-registered device maker in Dongguan Guangdong, China, 1 510(k) clearance
Dongguan Kangweile Electronic Technology Co., Ltd is registered with the FDA (registration 3017424877) in Dongguan Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017424877
- Address
- 4th floor, building D, Yizhong Science Park, 83 Jinsha 2nd Road, Shuikou village, Dalang Town, Dongguan City, Dongguan Guangdong, China, 523770
- Owner or operator
- Dongguan kangweile Electronic Technology Co., Ltd (10083307)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 9, 2021
- Registered through
- 2026
- Brand names listed
- Electronic Blood Pressure Monitor (Arm Type) KWL-818.KWL-819.KWL-B819L.KWL-B21L.KWL-B22L.KWL-819L, Electronic Blood Pressure Monitor (Arm Type) KWL-B01.KWL-B02.KWL-B03.KWL-B04.KWL-B05.KWL-B06.KWL-B07.KWL-B08.KWL-B09, Electronic Blood Pressure Monitor (Arm Type) KWL-B112.KWL-B168.KWL-B01L.KWL-B116.KWL-B606.KWL-B808.KWL-B698.KWL-B816, Electronic Blood Pressure MonitorKWL-B118.KWL-B106, Electronic Blood Pressure MonitorKWL-B619.KWL-B13.KWL-B15.KWL-B18.KWL-B17, Electronic Blood Pressure MonitorKWL-W01., Electronic Blood Pressure MonitorKWL-W01.KWL-W02.KWL-W03.KWL-W06.KWL-W08.KWL-W09.KWL-W01L
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2023 | K230642 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Dongguan Kangweile Electronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.