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Data / Medical devices / China / Shijiazhuang Aofeite Medical Device Co.,Ltd

Shijiazhuang Aofeite Medical Device Co.,Ltd: FDA-registered device maker in Shijiazhuang Hebei, China, 1 510(k) clearance

Shijiazhuang Aofeite Medical Device Co.,Ltd is registered with the FDA (registration 3009068676) in Shijiazhuang Hebei, China. It lists 28 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2021. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Shijiazhuang Aofeite Medical Device Co.,Ltd
FDA registration number
3009068676
Address
2nd Floor, Building 3D, Liandong U-Valley Industrial Park, No.695 Tianshan South Street, High-tech Zone, Shijiazhuang Hebei, China, 050000
Owner or operator
Shijiazhuang Aofeite Import and Export Co.,Ltd (10034267)
Roles
Exporter to the US, Manufacturer
First device listed
November 18, 2010
Registered through
2026
Brand names listed
Air mattress, Air neck traction, Anti Snore Belt, Anti Snore Jaw Supporter, Arthritis Gloves, BOTTLE, HOT/COLD WATER, Back/lumbar/waist support brace belt, Breathing Muscle Trainer and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, Traction, Non-PoweredHST1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, IceKYR1Exporter to the US, Manufactureraccessdata.fda.gov
Band Or Belt, Pelvic SupportISR1Exporter to the US, Manufactureraccessdata.fda.gov
Bottle, Hot/Cold WaterFPF1Exporter to the US, Manufactureraccessdata.fda.gov
Cane, Safety WalkKHY1Exporter to the US, Manufactureraccessdata.fda.gov
Cover, LimbIPM1Exporter to the US, Manufactureraccessdata.fda.gov
CrutchIPR1Exporter to the US, Manufactureraccessdata.fda.gov
Device, AcupressureMVVUExporter to the US, Manufactureraccessdata.fda.gov
Dilator, NasalLWF1Exporter to the US, Manufactureraccessdata.fda.gov
Exerciser, Non-MeasuringION1Exporter to the US, Manufactureraccessdata.fda.gov
Insoles, MedicalKYS1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Ankle, External BraceITW1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Knee, External BraceITQ1Exporter to the US, Manufactureraccessdata.fda.gov
Mask, ScavengingKHA1Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Exporter to the US, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ManualLYG1Exporter to the US, Manufactureraccessdata.fda.gov
Mattress, Flotation Therapy, Non-PoweredIKY1Exporter to the US, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Limb BraceIQI1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, Truncal/Orthosis, LimbMRI1Exporter to the US, Manufactureraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Exporter to the US, Manufactureraccessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)HOY1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-SterileNOC1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Exporter to the US, Manufactureraccessdata.fda.gov
Support, ArmIOY1Exporter to the US, Manufactureraccessdata.fda.gov
Surgical Table CushionLWG1Exporter 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
September 1, 2021K211823Bonine Acupressure BandsMVVSubstantially EquivalentWellspring Pharmaceutical Corporationaccessdata.fda.gov

Compare with other makers

Updated September 1, 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.