Foshan Kycare Medical Equipment Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Foshan Kycare Medical Equipment Co., Ltd. makes
Foshan Kycare Medical Equipment Co., Ltd. manufactures oxygen concentrators, including models J10A and J5A, designed for medical oxygen delivery in clinical and homecare settings.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
Oxygen Concentrator (J10A) Ref K251534
Regimes: 510(k) Registry: 510(k)Oxygen Concentrator (J5A) Ref K251607
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 976062605
FDA establishments
- Foshan Kycare Medical Equipment Co. Ltd Foshan City Guangdong · CN FEI 3033859527
Frequently asked questions
How many devices does Foshan Kycare Medical Equipment Co., Ltd. have in the registry?
The registry currently lists 3 devices for Foshan Kycare Medical Equipment Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Foshan Kycare Medical Equipment Co., Ltd.'s devices?
Among its 3 most recently registered devices, Foshan Kycare Medical Equipment Co., Ltd. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Foshan Kycare Medical Equipment Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Foshan Kycare Medical Equipment Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Foshan Kycare Medical Equipment Co., Ltd. in the registry?
The most recently registered devices listed for Foshan Kycare Medical Equipment Co., Ltd. include KYCARE FRPA6V-0, Oxygen Concentrator (J10A) and Oxygen Concentrator (J5A).
Which FDA establishments are linked to Foshan Kycare Medical Equipment Co., Ltd.?
1 FDA establishment is linked to Foshan Kycare Medical Equipment Co., Ltd. in the registry; they are listed on the company page.