BEUDAMED
    FDA Registration Active 🇨🇳 China

    VenAir Sequential Compression System

    Reg #: 3006339858 · FEI: 3006339858 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Apex Medical (Kunshan) Corp.
    Registration Number
    3006339858
    FEI Number
    3006339858
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1368, Zi Zhu Rd., Kunshan Kai Fa Hi-Tech,
    City
    Kunshan City Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K213577

    Owner / Operator

    Firm Name
    Wellell Inc.
    Operator Number
    9001426
    Address
    No. 9, MIN SHENG ST., TU-CHENG,
    City
    NEW TAIPEI CITY
    State
    TW-TPE
    Postal Code
    236044
    Country
    TW
    Correspondent
    Chieh - Yang

    US Agent

    Business Name
    WELLELL AMERICA CORP.
    Contact Name
    Elsa Chu
    Address
    927 Mariner Street, Brea, CA 92821, USA
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US
    Email
    [email protected]
    Phone
    714 6713818

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    VenAir Sequential Compression System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)