BEUDAMED
    FDA Registration Active 🇨🇳 China

    Shenzhen OSTO Medical Technology Company Limited

    Reg #: 3011564440 · FEI: 3011564440 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    24
    Establishment Types
    5
    Classifications
    11

    Registration Details

    Registration Name
    Shenzhen OSTO Medical Technology Company Limited
    Registration Number
    3011564440
    FEI Number
    3011564440
    Status
    Active
    Expiry Year
    2026
    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
    K133929

    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
    Massager, Therapeutic, Manual LYG
    Over-The-Counter Powered Light Based Laser For Acne OLP
    Light Based Over The Counter Wrinkle Reduction OHS
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Pad, Heating, Powered IRT
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Massager, Therapeutic, Electric ISA
    Device, Rebreathing BYW

    Proprietary Names

    Circulation Plus-Health Expert Electronic Stimulator (Model: AST-300C, AST-300D) Advanced Foot Energizer-Health Expert Electronic Stimulator (Model: AST-300C, AST-300D) Neck Care Therapy AST-905B Health Expert Electronic Stimulator (model: AST-300L) Multifunctional beauty device AST-B60 LED Facial Mask, Anti-wrinkle, Acne treatment, Model No AST-H606; LED Facial Wand Model No D103, Anti-wrinkle, Penguin 4 LED Light Platinum Therapy Face Mask (Prospera DL038 reference to AST-804B) LED Facial Mask, Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B Promote absorption of skin care products Low-frequency stimulator (Model AST-645, AST-646) Low-frequency Multi-function physiotherapy instrument AST-603, AST-2012A, AST-2012B NECK CARE THERAPY (model: AST-905A, AST-905D, AST-905H) AST-2011A, AST-2011B, AST-802B Physiotherapy instrument Health Expert Electronic Stimulator-AST-300F, AST-300H, AST-300J Heating Lumbar Therapy Cushion (model: AST-622, AST-622B, AST-623, AST-623B) Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) Knee Massager AST-649, hand massager AST-H61 Air Pressure Foot MassagerAST-X10, AST-X10B, AST- X11, AST-X11B,AST-X12,AST-X20; Eye massager Model AST-211, AST-212 AST-213, AST-214, AST-E10 Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) Oxygen concentrator concentrator, Model No: AST -608, AST-809, AST-809

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device