Jiangxi Royall Smart Technology Co., Ltd.

Manufacturer and brand owner in Ganzhou, Jiangxi, China. 5 device types, 1 product catalogued, 1 clearance.

Registry build 21.09.26

Jiangxi Royall Smart Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Toothbrush, Powered, Unit, Oral Irrigation and 3 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2022.

5device types registered with the FDA
1product
1510(k) clearance

Registration

FDA registration record for Jiangxi Royall Smart Technology Co., Ltd.
Registered name JIANGXI ROYALL SMART TECHNOLOGY CO., LTD.
Status Registered
Registration expires 2026
Registration number 3026164517
FEI number 3026164517
DUNS 554514493
Establishment type Manufacturer

Location

Address of Jiangxi Royall Smart Technology Co., Ltd.
City Ganzhou
Province Jiangxi
Address Building 1, 2nd-3rd Floor and Building 3, 2nd Floor, Lefeng Technology Park, Northern Area
Postal code 341200
Country China

What It Makes

Device types Jiangxi Royall Smart Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Stimulator, Electrical, Transcutaneous, For Arthritis Class 2 TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04) 2023 22
Stimulator, Muscle, Powered, For Muscle Conditioning Class 2 TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04) 2023 66
Stimulator, Nerve, Transcutaneous, Over-The-Counter Class 2 TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04) 2023 57
Toothbrush, Powered Class 1 Sonic Electric Toothbrush (model: YM3), Sonic Electric Toothbrush (model: YM3(W)), 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)) 2024 191
Unit, Oral Irrigation Class 1 Oral Irrigator (Model: C2, C5, C6), Water flosser (model: CL1, CL2, CL1(W), CL2(W)) 2022 128

Own-Brand Listings

Devices catalogued by Jiangxi Royall Smart Technology Co., Ltd.
Product Code Catalogue numbers
Equate NYN 1

Clearances

510(k) clearances naming Jiangxi Royall Smart Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K230443 2023-05-22 NUH Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Jiangxi Royall Smart Technology Co., Ltd.
Founded 2018
Employees 500
Main products Oral care products, EMS products, TNS products
Certifications ISO9001, ISO14001, ISO45001
OEM and ODM Offered

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer