Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023237645

FEI Number

3023237645

Entity Name

BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD.

City/State/Country

Bozhou Anhui, CN

Establishment Address

Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou Anhui 233500, CN

Establishment Type(s)

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

Owner / Operator

Bozhou Rongjian Medical Appliance Co., Ltd. (Owner Number: 10084937)

Owner / Operator Contact Address

Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou, CN-AH 233500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K252688

PMA Number

N/A

All Registered Proprietary Names

Self-adhesive Electrode Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) Transcutaneous Electrical Nerve Stimulator (RJTENS-2)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-04-17
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2023-01-29
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-12-05

Official Correspondent

Zhifang Wu

US Agent Details

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

Related Public Records

Same Entity

Bozhou Rongjian Medical Appliance 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
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
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

Registration Number	Establishment Name	Location
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3015429360	SHAOXING YINGTUO HEALTHCARE CO.,LTD.	Shaoxing Zhejiang, CN
3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023237645. Last updated year: 2026. Please use registration number 3023237645 when referencing this establishment in official correspondence.