BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD

    Reg #: 3013671142 · FEI: 3013671142 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    39
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
    Registration Number
    3013671142
    FEI Number
    3013671142
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232517

    Owner / Operator

    Firm Name
    SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
    Operator Number
    10055119
    Address
    2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518115
    Country
    CN
    Correspondent
    Zewu Zhang

    US Agent

    Business Name
    LLINS TECHNOLOGY INC
    Contact Name
    James Wang
    Address
    1312 17th street Unit #2199, Denver
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    720 2171916

    Products

    Device Name Product Code
    Stimulator, Electrical, Transcutaneous, For Arthritis NYN
    Stimulator, Nerve, Transcutaneous, Over-The-Counter NUH
    Stimulator, Muscle, Powered, For Muscle Conditioning NGX
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Stimulator, Muscle, Powered IPF
    Electrode, Cutaneous GXY
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Rosi(KTR-2412) Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) Magic TENS FDA-Approved Pain Relief System for Whole-Body, Menstrual & Arthritis Pain (Prospera PL029A refer to KTR-2402 Low-Frequency Therapy Instrument KTR-202 KTR-206 MGEP-206P KTR-201 KTR-203 SA-PCA008 Muscle Trainer, models: KTR-230 series, KTR-231, KTR-232, KTR-233, KTR-234 pursonic(KTR-231) Transcutaneous Electrical Nerve Stimulator (Models: KTR-2222, KTR-2210, KTR-2211, KTR-2212) Transcutaneous Electrical Nerve Stimulator (Models: KTR-2230, KTR-2231, KTR-2232, KTR-2220, KTR-2221) Transcutaneous Electrical Nerve Stimulator (Models: KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) Transcutaneous Electrical Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302) Smart Stim Transcutaneous Electrical Joint Stimulation Device Transcutaneous Electrical Nerve Stimulator (RHB2029 reference to KTR-2493) Hammacher Schlemmer (KTR-2493) ART Transcutaneous Electrical Joint Stimulation Device Transcutaneous Electrical Nerve Stimulator (Model: KTR-2240, KTR-2250, KTR-2241, KTR-2251, KTR-2242, KTR-2252) Transcutaneous Electrical Nerve Stimulator ( Model:KTR-2612, KTR-2642, KTR-2652) Transcutaneous Electrical Nerve Stimulator ( Model:KTR-2610, KTR- 2640, KTR-2650, KTR-2611, KTR-2641, KTR-2651) Transcutaneous Electrical Nerve Stimulator (RHB3004 reference to KTR-2610) Smart-Wave(KTR-2610) Transcutaneous Electrical Nerve Stimulator (Boston Tech ME91 reference to KTR-2610) Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 Transcutaneous Electrical Nerve Stimulator(Model: KTR-4026, KTR-4021, KTR- 4034, KTR-4036, KTR-4037, KTR-4039) Transcutaneous Electrical Nerve Stimulator(Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027) Sunnyload Transcutaneous Electrical Nerve Stimulator(Model: KTR-4015) Cutaneous Electrode Transcutaneous Electrical Nerve Stimulator (Models: KTR-206, KTR-208, KTR-209) Transcutaneous Electrical Nerve Stimulator (RHB1043 refer to KTR-208) Neck Massager (Models: KTR-129, KTR-140, KTR-132, KTR-140, MGEP-140) Electrode pads Electrode pads (RHB2029PAK2, RHB2029PAK20) Penguin Electronic Pulse TENS EMS (Prospera PL009B reference to KTR-2401) Smart Stim Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device