BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    POWER WELL HEALTHCARE TECHNOLOGY CO., LTD.

    Reg #: 3014144875 · FEI: 3014144875 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    POWER WELL HEALTHCARE TECHNOLOGY CO., LTD.
    Registration Number
    3014144875
    FEI Number
    3014144875
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.26, Lane 222, Lunzijiao Road, Xihu Township
    City
    Changhua County
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K092892

    Owner / Operator

    Firm Name
    Power Well Healthcare Technology Co., Ltd.
    Operator Number
    10056225
    Address
    No.26, Lane 222, Lunzijiao Road, Xihu Township
    City
    Changhua County
    State
    TW-CHA
    Postal Code
    514
    Country
    TW

    US Agent

    Business Name
    ROC Chinese-European Industrial Research Society
    Contact Name
    Shu-Chen Cheng
    Address
    2064 Tamarin Dr
    City
    Columbus
    State
    OH
    ZIP
    43235
    Country
    US
    Email
    [email protected]
    Phone
    614 5888168

    Products

    Device Name Product Code
    Band Or Belt, Pelvic Support ISR
    Pad, Heating, Powered IRT
    Splint, Temporary Training IQM
    Stocking, Medical Support (For General Medical Purposes) FQL
    Support, Hernia EXN
    Orthosis, Lumbar IQE
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Binder, Breast HEF
    Orthosis, Cervical IQK
    Binder, Abdominal FSD
    Support, Arm IOY
    Joint, Elbow, External Limb Component, Mechanical IRD
    Joint, Ankle, External Brace ITW
    Splint, Clavicle IQJ
    Binder, Elastic KMO
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL
    Sleeve, Limb, Compressible JOW
    Sling, Arm ILI
    Bandage, Elastic FQM
    Joint, Knee, External Brace ITQ
    Splint, Extremity, Noninflatable, External, Sterile FYH
    Insoles, Medical KYS

    Proprietary Names

    Pelvic Support Powered Heating Pad Temporary Training Splint Face Mask (Except N95 Respirator) Hernia Support Lumbar Orthosis Breast Binder Cervical Support Abdominal Binder Arm Support Limb and Elbow Binder Ankle Brace Clavicle Splint Elastic Binder Medical Prevent Pooling of Blood in Legs Stocking Compressible Limb Stocking Arm Sling Elastic Bandage Knee Brace Sterile External Splint Medical Insoles

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device