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Data / Medical devices / Taiwan / Power Well Healthcare Technology Co., Ltd.

Power Well Healthcare Technology Co., Ltd.: FDA-registered device maker in Changhua County, Taiwan, 1 510(k) clearance

Power Well Healthcare Technology Co., Ltd. is registered with the FDA (registration 3014144875) in Changhua County, Taiwan. It lists 22 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 2010. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this oneWatch Power Well Healthcare Technology Co., Ltd.
FDA registration number
3014144875
Address
No.26, Lane 222, Lunzijiao Road, Xihu Township, Changhua County, Taiwan, 514
Owner or operator
Power Well Healthcare Technology Co., Ltd. (10056225)
Roles
Exporter to the US, Manufacturer
First device listed
November 16, 2017
Registered through
2026
Brand names listed
Abdominal Binder, Ankle Brace, Arm Sling, Arm Support, Breast Binder, Cervical Support, Clavicle Splint, Compressible Limb Stocking and more

Devices it lists

DeviceProduct codeClassRoleSource
Band Or Belt, Pelvic SupportISR1Exporter to the US, Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the US, Manufactureraccessdata.fda.gov
Binder, AbdominalFSD1Exporter to the US, Manufactureraccessdata.fda.gov
Binder, BreastHEF1Exporter to the US, Manufactureraccessdata.fda.gov
Binder, ElasticKMO1Exporter to the US, Manufactureraccessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaQKRNExporter 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, Elbow, External Limb Component, MechanicalIRD1Exporter to the US, Manufactureraccessdata.fda.gov
Joint, Knee, External BraceITQ1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Exporter to the US, Manufactureraccessdata.fda.gov
Orthosis, LumbarIQE1Exporter to the US, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Exporter to the US, Manufactureraccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Exporter to the US, Manufactureraccessdata.fda.gov
Sling, ArmILI1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, ClavicleIQJ1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Extremity, Noninflatable, External, SterileFYH1Exporter to the US, Manufactureraccessdata.fda.gov
Splint, Temporary TrainingIQM1Exporter to the US, Manufactureraccessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)FQL1Exporter to the US, Manufactureraccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Exporter to the US, Manufactureraccessdata.fda.gov
Support, ArmIOY1Exporter to the US, Manufactureraccessdata.fda.gov
Support, HerniaEXN1Exporter 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
August 3, 2010K0928921-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613DWLSubstantially EquivalentI-Ming Sanitary Materials Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated August 3, 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.