Data / Medical devices / China / Dong Guan OU Kang Electronics Co.,ltd
Dong Guan OU Kang Electronics Co.,ltd: FDA-registered device maker in Dongguan Guangdong, China, 1 510(k) clearance
Dong Guan OU Kang Electronics Co.,ltd is registered with the FDA (registration 3015060202) in Dongguan Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015060202
- Address
- 3rd floor, Xiqunli building, Shipai road, Yanwo village, Shipai town, Dongguan Guangdong, China, 523000
- Owner or operator
- Dong Guan Ou Kang Electronics CO.,LTD (10058931)
- Roles
- Manufacturer
- First device listed
- November 12, 2018
- Registered through
- 2026
- Brand names listed
- Oukang, Self-adhesive electrode, Model: Lead wire type electrode; snap type electrode
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | 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 7, 2018 | K181234 | Self-adhesive Electrode | GXY | Substantially Equivalent | Dong Guan OU Kang Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 7, 2018. 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.