SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3013671142

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013671142
FEI Number
3013671142
Entity Name
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, Shenzhen Guangdong 518115, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD (Owner Number: 10055119)
Owner / Operator Contact Address
2nd Floor, No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, Shenzhen, CN-GD 518115, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K183288
PMA Number
N/A

All Registered 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)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2024-01-15
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2024-01-15
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2017-06-09
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2018-10-22
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2020-11-19
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2020-11-19
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2020-11-19
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2021-12-03
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2021-12-03
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2022-08-24
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2022-08-24
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2022-08-24
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2022-08-24
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2022-08-24
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2023-11-19
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2023-11-19
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Neurology Class 2 882.5890 2023-11-19
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2023-11-19
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2023-11-19
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2024-08-22
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2019-07-30
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2019-07-30
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2019-07-30

Official Correspondent

Zewu Zhang

US Agent Details

James Wang Business: LLINS TECHNOLOGY INC Email: fda-rep@llins-tech.com Phone: (720) 2171916

Related Public Records

Same Entity

SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K221200 Xbody Hungary Kft. XBody Go USA, XBody Pro USA 2023-01-31
K122948 Gemore Technology Co, Ltd. GEM-STIM COMBO STIMULATOR 2012-12-21
K033455 Biomedical Life Systems, Inc. ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 2004-01-15
K810593 Medical Devices, Inc. NEUROPAC ULTRA I 1981-03-13
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17

Similar Registrations

Registration Number Establishment Name Location
3003255790 WITKO INCORPORATED Wolcott, IN, US
3038295706 JUST KEEP HEALTHY CO., LTD. Samkkei Munichay District Kampong Speu, KH
3007731000 VGH SOLUTIONS INC Markham Ontario, CA
3008048783 DRTV Asia LTD Panyu GuangZhou Guangdong, CN
3008507279 CHOICEMMED AMERICA CORPORATION Bristol, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013671142. Last updated year: 2026. Please use registration number 3013671142 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.