Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026164517

FEI Number

3026164517

Entity Name

JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.

City/State/Country

Ganzhou Jiangxi, CN

Establishment Address

Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area, Huangbu Industrial Park, Shangyou County, Ganzhou Jiangxi 341200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Jiangxi Royall Smart Technology Co., Ltd. (Owner Number: 10086681)

Owner / Operator Contact Address

Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area, Huangbu Industrial Park, Shangyou County, Ganzhou, CN-JX 341200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230443

PMA Number

N/A

All Registered Proprietary Names

Sonic Electric Toothbrush (model: YM3) Sonic Electric Toothbrush (model: YM502(W), YM502(B), YM502(E), TBM10T, TBM11T, LY-T01) Sonic Electric Toothbrush (model: YM6(W), YM6(B), YM6(E), YM6Pro(W), YM6Pro(B), YM6Pro(E)) Sonic Electric Toothbrush (model: YM3(W)) TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-06-05
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2023-05-26
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2023-05-26
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2023-05-26

Official Correspondent

Yuheng Huang

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Jiangxi Royall Smart 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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026164517. Last updated year: 2026. Please use registration number 3026164517 when referencing this establishment in official correspondence.