Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038276093

FEI Number

3038276093

Entity Name

SINOSHINE HEALTH TECHNOLOGY CO., LTD

City/State/Country

Tan Uyen City Binh Duong, VN

Establishment Address

No. 10, Road DT 747B, Quarter 7, Uyen Hung Ward, Tan Uyen City, Binh Duong Province, Vietnam., Tan Uyen City Binh Duong 75406, VN

Establishment Type(s)

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

Owner / Operator

SINOSHINE HEALTH TECHNOLOGY CO., LTD (Owner Number: 10090867)

Owner / Operator Contact Address

No. 10, Road DT 747B, Quarter 7, Uyen Hung Ward, Tan Uyen City, Binh Duong Province, Vietnam., Tan Uyen City, VN-57 75406, VN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GWM-02A; GWM-02A/GWM-02B; GWM-02B, GWM-02C; GWM-03A; GWM-03B; GWM-03C HB18A-XXEE-7; UHP 24/25/26/27/48/54, HD 74, maybe even add UWB70/80 HB189NC-124; HB189NC-1733, HB189NC-1-5060; HB189NC-1-6284 H-5525-1, H-5527-1, H-5525-2, H-5527-2, HB186NA-1224; HB186NA-2025; HB186-20.522 GWM-04A; GWM-04B; GWM-04C; GWM-05A; GWM-05B; GWM-05C; HB169-12x24 HB18A-XXYY-1; HB18A-XXZZ-2; HB18A-XXAA-3; HB18A-XXBB-4; HB18A-XXCC-5; HB18A-XXDD-6 Period Pain Relief; Massage Heating Pad; sshine; SHk 42 HB18A-1224-1; HB18A-1834-5; Heating Pad; Heating Pad CH2; heating pad for Abdomen U-SP16B; U-SP16N; USP16S; USP16R; USP16RX; USP16RC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-04-29

Official Correspondent

Ronghua Cai

US Agent Details

Aokai Tang Business: AOKT STUDIO LLC Email: aokt-service@outlook.com Phone: (757) 2240177

Related Public Records

Same Entity

SINOSHINE HEALTH 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
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Similar Registrations

Registration Number	Establishment Name	Location
3014113673	DONGGUAN XINJIN THERMO CONTROL MANUFACTURING CO., LTD.	DONGGUAN CITY Guangdong, CN
3042277608	LIAONING DIKANGYUAN HEALTH TECHNOLOGY CO.,LTD.	LIAOYANG Liaoning, CN
3013284090	SHENZHEN H&T INTELLIGENT CONTROL CO., LTD.	Shenzhen Guangdong, CN
3014290933	Wuhu OWFine Electronic Technology Co., Ltd.	Wuhu Anhui, CN
3026312365	BEIJING ETERNAL MEDICAL TECHNOLOGY CO.,LTD.	Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038276093. Last updated year: 2026. Please use registration number 3038276093 when referencing this establishment in official correspondence.