BEUDAMED
    FDA Registration Active 🇨🇳 China

    Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

    Reg #: 3011564440 · FEI: 3011564440 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    Shenzhen OSTO Medical Technology Company Limited
    Registration Number
    3011564440
    FEI Number
    3011564440
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road, Longgang Street, Longgang District,
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K182136

    Owner / Operator

    Firm Name
    Shenzhen OSTO Medical Technology Company Limited
    Operator Number
    10048304
    Address
    2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road (Longgang Section), Longxin Community, Baolong Street, Longgang District
    City
    Shenzhen City
    State
    Guangdong
    Postal Code
    518116
    Country
    CN
    Correspondent
    Yang Lee

    US Agent

    Business Name
    Liberty Management Group Ltd.
    Contact Name
    Manoj Zacharias
    Address
    75 Executive Drive,, Suite 114,
    City
    Aurora
    State
    IL
    ZIP
    60504
    Country
    US
    Email
    [email protected]
    Phone
    630 2702921

    Products

    Device Name Product Code
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH

    Proprietary Names

    Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

    Establishment Types

    Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device