BEUDAMED
    FDA Registration Active 🇨🇳 China

    Ice Bucket; Cold Therapy System; Sleeve, Limb, Compressible Garment;

    Reg #: 3016969935 · FEI: 3016969935 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SHANGHAI YOUWEN MEDICAL TECHNOLOGY CO.,LTD.
    Registration Number
    3016969935
    FEI Number
    3016969935
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 319,28# Building,NO.199 Haifu Road, Jinshan District
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K110276

    Owner / Operator

    Firm Name
    Shanghai Youwen Medical Technology Co.,Ltd.
    Operator Number
    10083175
    Address
    Room 319,28# Building,NO.199 Haifu Road, Jinshan District
    City
    Shanghai
    State
    CN-NOTA
    Postal Code
    201508
    Country
    CN
    Correspondent
    Honggang Chen

    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
    Massager, Powered Inflatable Tube IRP
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    Ice Bucket; Cold Therapy System; Sleeve, Limb, Compressible Garment; Air Compression Leg Massager V1; Air Compression Calf Massager V1; Cold therapy set; Cold compression system Air compression waist massager with heat;

    Establishment Types

    Manufacture Medical Device