BEUDAMED
    FDA Registration Active 🇨🇳 China

    ABLETECH ORTHOPEDICS CORPORATION

    Reg #: 3034694939 · FEI: 3034694939 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    ABLETECH ORTHOPEDICS CORPORATION
    Registration Number
    3034694939
    FEI Number
    3034694939
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    15F-3 No.1 Baosheng Rd., Yonghe Dist.
    City
    New Taipei City Taiwan
    Country
    CN

    Owner / Operator

    Firm Name
    Abletech Orthopedics Corporation
    Operator Number
    10092117
    Address
    15F-3 No.1 Baosheng Rd., Yonghe Dist.
    City
    New Taipei City
    State
    Taiwan
    Postal Code
    234635
    Country
    CN
    Correspondent
    Ramon Tseng

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Stirrup, External Brace Component ITC
    Orthosis, Corrective Shoe KNP
    Joint, Ankle, External Brace ITW
    Sling, Arm, Overhead Supported ILE
    Band Or Belt, Pelvic Support ISR
    Orthosis, Cervical-Thoracic, Rigid IQF
    Splint, Hand, And Components ILH
    Joint, Hip, External Brace ITS
    Pack, Hot Or Cold, Disposable IMD
    Orthosis, Lumbo-Sacral IPY
    Cushion, Flotation KIC
    Joint, Knee, External Brace ITQ
    Splint, Extremity, Inflatable, External FZF
    Support, Arm IOY
    Orthosis, Limb Brace IQI
    Apparatus, Traction, Non-Powered HST
    Sling, Arm ILI
    Splint, Abduction, Congenital Hip Dislocation IOZ
    Orthosis, Truncal, For Dysmenorrhea NJB
    Splint, Clavicle IQJ
    Orthosis, Truncal/Orthosis, Limb MRI

    Proprietary Names

    Stirrup, External Brace Component Orthosis, Corrective Shoe Joint, Ankle, External Brace Sling, Arm, Overhead Supported Band or Belt Pelvic Support (Proprietary Name) Orthosis Cervical Thoracic Rigid Splint, Hand, And Components Joint, Hip, External Brace Pack, Hot or Cold Disposable Orthosis Lumbo-Sacral Cushion Flotation Joint, Knee, External Brace Splint, Extremity, Inrlatable, External Support, Arm Orthosis, Limb Brace Apparatus, Traction, non powered Sling, Arm Splint, Abuction, Congenital Hip Dislocation Orthosis, Trucal, for dysmenorrhea Splint, Clavicle Orthosis, Truncal/Orthosis, Limb

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)