BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.

    Reg #: 3014314933 · FEI: 3014314933 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    36
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD.
    Registration Number
    3014314933
    FEI Number
    3014314933
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    202,2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K192087

    Owner / Operator

    Firm Name
    Shenzhen Roundwhale Technology Co. Ltd.
    Operator Number
    10057039
    Address
    202,2/F, Building 27, Dafa Industrial Park, Longxi Community, Longgang Street, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518116
    Country
    CN
    Correspondent
    Kevin Zhang

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr.
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Cable, Electrode IKD
    Electrode, Cutaneous GXY
    Massager, Therapeutic, Electric ISA
    Interferential Current Therapy LIH

    Proprietary Names

    ISTIM M2 TME-UTA BRVE2 ZZACOMBOBDPT1 R-C101J, R-C3,R-C4A,R-C4B,R-C4C,R-C4D,CNT-TENS-100,Magic, M100A, M101A, R-C1-K01,M102A TENS 3N1, TENS 3N1R, TENS 12MT, TENS 3MT, TENS 7500, R-C5 Combo Electrotherapy Device (Magic), Combo Electrotherapy Device (R-C101J),AE177 R-C4D-RW1 ZZACOMBOBDPT2 RHB2026GRY Combo Electrotherapy Device (M101A-UK1) ZZACOMBO Electrode Cable Self-Adhesive Electrode Self-Adhesive Electrode with lead wire Self-Adhesive Electrode with Snap/Magnetic connector MASSAGER: R-C1,R-T1,R-E1,R-C3,R-C4A,R-C4B,R-C4C,R-C4D Combo Electrotherapy Device(Model:R-C10IW,R-C101A,R-C101B,R-C101E,R-C101H,R-C101D,R-C101G) TENS and EMS Stimulator R-C1/R-T1/R-E1 EMS Stimulator R-E1 TENS Stimulator R-T1 TENS and EMS Stimulator R-C1 AHC-T7K Combo Electrotherapy Device (Model: R-C101C, R-C101D, R-C101F, R-C101G,F100, MINI TENS COMB,R-C101I,TENS3500,R-C101K) ISTIM SOOTHE 1 ePower®E1 R-C112B ME 89+ Neurological Therapy Devices - Accessories (Model:AC1001 AC1002 AC1003 AC1004 AC1005) Neurological Therapy Devices - Accessories (Model:AC7001 AC7002 AC7003) Neurological Therapy Devices - Accessories (Model:AC4001 AC4002 AC4003 AC5001 AC5002 AC5003) Neurological Therapy Devices - Accessories (Model:AC2001 AC2002 AC2003 AC2004) Neurological Therapy Devices - Accessories (Model:AC8001 AC9001) Neurological Therapy Devices - Accessories (Model:AC3002 AC3004 AC3006 AC3003 AC3005 AC3007) Neurological Therapy Devices - Accessories (Model:AC3001 AC3008 AC3009 AC3010 AC3011)

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)