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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

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the US, Manufactureraccessdata.fda.gov
Adaptor, Holder, SyringeIQG1Exporter to the US, Manufactureraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Exporter to the US, Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Exporter to the US, Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the US, Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Manufactureraccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Exporter to the US, Manufactureraccessdata.fda.gov
Device, Prosthesis AlignmentIQO1Manufactureraccessdata.fda.gov
Device, RebreathingBYW1Exporter to the US, Manufactureraccessdata.fda.gov
Exerciser, Finger, PoweredJFA1Manufactureraccessdata.fda.gov
Gag, MouthKBN1Exporter to the US, Manufactureraccessdata.fda.gov
Gown, ExaminationFME1Exporter to the US, Manufactureraccessdata.fda.gov
Hand, External Limb Component, PoweredIQZ1Manufactureraccessdata.fda.gov
Helmet, SurgicalFXZ1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the US, Manufactureraccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Pump, Nebulizer, Electrically PoweredJPW1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Contract manufactureraccessdata.fda.gov
Support, ArmIOY1Exporter to the US, Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 23, 2021K212169Air compression therapy system FO3002IRPSubstantially EquivalentFoshan Hongfeng Co., Ltd.accessdata.fda.gov
March 25, 2021K201982Air compression therapy system FO-3001; Air compression therapy system FO-3008IRPSubstantially EquivalentFoshan Hongfeng Co., Ltd.accessdata.fda.gov
November 10, 2009K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
December 21, 2005K052811HSINER JET NEBULIZER, MODEL HS-31100CAFSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov

Compare with other makers

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.