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Data / Medical devices / China / Global Fabtech Wheel Chair (shanghai) Co., Ltd.

Global Fabtech Wheel Chair (shanghai) Co., Ltd.: FDA-registered device maker in Shanghai, China, 4 510(k) clearances

Global Fabtech Wheel Chair (shanghai) Co., Ltd. is registered with the FDA (registration 3003882673) in Shanghai, China. It lists 15 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 4, 2010. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Global Fabtech Wheel Chair (shanghai) Co., Ltd.
FDA registration number
3003882673
Address
No. 318 Tianfu Road JIUTING, SONGJIANG, Shanghai, China, 201615
Owner or operator
GLOBAL FABTECH WHEEL CHAIR (SHANGHAI) CO., LTD. (9043991)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
January 24, 2008
Registered through
2027
Brand names listed
Fiji Sun Fluorescent Tanning Unit (FIJI Sun), KBD, Spertilite Phototherapy Lamp, Zip'r, Zip'r Mantis, Zip'r Mobility, Zip'r PC, Zip'r3 and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, WheelchairKNO1Manufactureraccessdata.fda.gov
Armrest, WheelchairIML1Exporter to the USaccessdata.fda.gov
Booth, Sun TanLEJ2Contract manufactureraccessdata.fda.gov
Components, WheelchairKNN1Manufactureraccessdata.fda.gov
Cuff, Pusher, WheelchairINC1Manufactureraccessdata.fda.gov
Cushion, WheelchairIMP1Exporter to the USaccessdata.fda.gov
Device, Anti-Tip, WheelchairIMR1Manufactureraccessdata.fda.gov
Footrest, WheelchairIMM1Manufactureraccessdata.fda.gov
Holder, Crutch And Cane, WheelchairIMZ1Repackager or relabeleraccessdata.fda.gov
Light, Ultraviolet, DermatologicalFTC2Contract manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Contract manufactureraccessdata.fda.gov
Sunlamp Products (Pre-Standard)RAB2Contract manufactureraccessdata.fda.gov
Support, Head And Trunk, WheelchairIMS1Repackager or relabeleraccessdata.fda.gov
Vehicle, Motorized 3-WheeledINI2Manufactureraccessdata.fda.gov
Wheelchair, PoweredITI2Manufactureraccessdata.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
October 4, 2010K102361ZIP'R4/ ZIP'R4 XTRA SCOOTERINISubstantially EquivalentGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.accessdata.fda.gov
October 4, 2010K102358ZIP'R3/ ZIP'R3 XTRA SCOOTERINISubstantially EquivalentGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.accessdata.fda.gov
October 4, 2010K102355ZIP'R MANTIS POWERED WHEELCHAIRITISubstantially EquivalentGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.accessdata.fda.gov
September 21, 2007K072224ZIP'R PCITISubstantially EquivalentGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 4, 2010. 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.