Data / Medical devices / China / Foshan Hongfeng Co.,ltd
Foshan Hongfeng Co.,ltd: FDA-registered device maker in Foshan Guangdong, China, 4 510(k) clearances
Foshan Hongfeng Co.,ltd is registered with the FDA (registration 3013440654) in Foshan Guangdong, China. It lists 25 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013440654
- Address
- No.4-2 Leqiang Road,leping Sanshui, Foshan Guangdong, China, 528100
- Owner or operator
- FOSHAN HONGFENG CO.,LTD (10053080)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 30, 2016
- Registered through
- 2026
- Brand names listed
- Air compression therapy system FO3002, Air compression therapy systemFO-3001, Air compression therapy systemFO-3001B, Air compression therapy systemFO-3001C, Air compression therapy systemFO-3001D, Air compression therapy systemFO-3001E, Air compression therapy systemFO-3008, Air compression therapy systemFO-3008B and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| November 23, 2021 | K212169 | Air compression therapy system FO3002 | IRP | Substantially Equivalent | Foshan Hongfeng Co., Ltd. | accessdata.fda.gov |
| March 25, 2021 | K201982 | Air compression therapy system FO-3001; Air compression therapy system FO-3008 | IRP | Substantially Equivalent | Foshan Hongfeng Co., Ltd. | accessdata.fda.gov |
| November 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
| December 21, 2005 | K052811 | HSINER JET NEBULIZER, MODEL HS-31100 | CAF | Substantially Equivalent | Hsiner Co., Ltd. | accessdata.fda.gov |
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Updated November 23, 2021. 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.