Data / Medical devices / China / Foshan Care Medical Technology Co., Ltd.
Foshan Care Medical Technology Co., Ltd.: FDA-registered device maker in Foshan Guangdong, China, 4 510(k) clearances
Foshan Care Medical Technology Co., Ltd. is registered with the FDA (registration 3008220943) in Foshan Guangdong, China. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008220943
- Address
- #2 Haitang Rd, National Ecological Industrial Park Danzao, Town, Nanhai District, Foshan Guangdong, China, 528000
- Owner or operator
- Foshan Care Medical Technology Co., Ltd. (10036239)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 25, 2011
- Registered through
- 2026
- Brand names listed
- CARE ZY5BA Oxygen Concentrator, Care Nebulizer, KYWH2001, KYWH2004, KYWH2006, Oxygen Concentrator (ZY-10AB/115), SU01A
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| December 6, 2024 | K240840 | Oxygen Concentrator (ZY-10AB/115) | CAW | Substantially Equivalent | Foshan Care Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 25, 2013 | K130001 | CARE SU01A SUCTION ASPIRATOR | JCX | Substantially Equivalent | Foshan Care Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 14, 2011 | K101552 | FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 | CAF | Substantially Equivalent | Foshan Care Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 9, 2010 | K102245 | CARE ZY5BA OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Foshan Care Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Apparatus, Suction, Ward Use, Portable, Ac-Powered
Updated December 6, 2024. 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.