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Fofo Medical Co.,ltd: FDA-registered device maker in Xiamen Fujian, China, 4 510(k) clearances

Fofo Medical Co.,ltd is registered with the FDA (registration 3045077467) in Xiamen Fujian, China. It lists 18 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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Fofo Medical Co.,ltd
FDA registration number
3045077467
Address
Room 1212A, No. 108 Hexiang East Road, Siming District, Xiamen Fujian, China, 361001
Owner or operator
FOFO medical co.,ltd (10095802)
Roles
Exporter to the US
First device listed
May 1, 2026
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 USaccessdata.fda.gov
Adaptor, Holder, SyringeIQG1Exporter to the USaccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, Non-SterileNNW1Exporter to the USaccessdata.fda.gov
Bedding, Disposable, MedicalKME1Exporter to the USaccessdata.fda.gov
Catheter, Nasal, OxygenBZB1Exporter to the USaccessdata.fda.gov
Device, RebreathingBYW1Exporter to the USaccessdata.fda.gov
Exerciser, Finger, PoweredJFA1Exporter to the USaccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Helmet, SurgicalFXZ1Exporter to the USaccessdata.fda.gov
Massager, Powered Inflatable TubeIRP2Exporter to the USaccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the USaccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Exporter to the USaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the USaccessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)CCQ1Exporter to the USaccessdata.fda.gov
Pack, Hot Or Cold, Water CirculatingILO2Exporter to the USaccessdata.fda.gov
Pump, Nebulizer, Electrically PoweredJPW1Exporter to the USaccessdata.fda.gov
Support, ArmIOY1Exporter to the USaccessdata.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.