Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038195193

FEI Number

3038195193

Entity Name

SHENZHEN JIANTUO ELECTRONICS CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

608, Block A, Zhuoyue Yulong Haoxuan, Xinyang Community, Shajing Street, Bao'an District, Shenzhen Guangdong 518104, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Jiantuo Electronics Co., Ltd (Owner Number: 10093000)

Owner / Operator Contact Address

608, Block A, Zhuoyue Yulong Haoxuan, Xinyang Community, Shajing Street, Bao'an District, Shenzhen, CN-GD 518104, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181234

PMA Number

N/A

All Registered Proprietary Names

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034, AS1080, AS2080) TENS AND EMS (TENS and Muscle Stimulator) (JT9020, JT2503B, JT9024, JT9035) Easy@Home TENS AND MUSCLE STIMULATOR (EHE029N) Electric massager Foot massager TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) Self-adhesive Electrode Pads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2026-01-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2026-01-05
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2025-03-15
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-05-11
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-05-11
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2026-03-22

Official Correspondent

John Zou

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

Shenzhen Jiantuo 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03

Similar Registrations

Registration Number	Establishment Name	Location
3015282440	MEDICAL CABLES S.L.	Malaga, ES
3015781781	WIEMSPRO S.L	Malaga, ES
3029924973	SHENZHEN SINREL TECH LTD	Shenzhen Guangdong, CN
3013889849	Expeditors International of Washington, Inc.	Salt Lake City, UT, US
3044675848	PEPPER INTERACTIVE INC	Wilmington, DE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038195193. Last updated year: 2026. Please use registration number 3038195193 when referencing this establishment in official correspondence.