Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005170249

FEI Number

3005170249

Entity Name

Shenzhen Dongdixin Technology Co., Ltd.

City/State/Country

SHENZHEN Guangdong, CN

Establishment Address

Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District,, SHENZHEN Guangdong 518108, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. (Owner Number: 9073156)

Owner / Operator Contact Address

Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate, Xilixiaobaimang Nanshan District,, SHENZHEN, CN-GD 518108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141076

PMA Number

N/A

All Registered Proprietary Names

TENS UNIT ETU-134

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-10-22
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2015-10-22
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2013-09-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2013-09-21
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-06-17
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2015-11-20
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2015-11-20
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2015-11-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2015-11-20
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2015-11-20
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2015-11-20
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-07-28
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2024-05-29
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2012-11-27
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2012-11-27
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5860	2012-11-27
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2023-06-13
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2023-06-13
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2023-06-13
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2023-06-13
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2012-06-18
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2017-10-20
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2017-10-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2017-10-20
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2010-02-05
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2010-02-05
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2010-03-18
LIH	Interferential Current Therapy	Neurology	Class 2	882.5890	2010-03-18
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2010-03-18
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2014-06-20
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2017-12-10
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2017-12-10
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2017-12-10
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2014-03-31
IMJ	Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2014-03-31
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2014-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

CHARLES MACK Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

SHENZHEN DONGDIXIN TECHNOLOGY 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
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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005170249. Last updated year: 2026. Please use registration number 3005170249 when referencing this establishment in official correspondence.