Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3044989687

FEI Number

3044989687

Entity Name

SHENZHEN MEIHUI OPTOELECTRONICS CO., LTD

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

West Floor 8, A2 ZhongTai Information Industrial Park Pioneering Domain, No2 Dezheng Road, ShiLongZai Community, ShiYan Town, BaoAn District, Shenzhen Guangdong 518108, CN

Establishment Type(s)

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

Owner / Operator

SHENZHEN MEIHUI OPTOELECTRONICS CO., LTD (Owner Number: 10095487)

Owner / Operator Contact Address

West Floor 8, A2 ZhongTai Information Industrial Park Pioneering Domain, No2 Dezheng Road, ShiLongZai Community, ShiYan Town, BaoAn District, Shenzhen, CN-GD 518108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sauna Blanket; Far Infrared Sauna Blanket; FIR Sauna Blanket; Infrared Sauna Blanket; Infrared Sauna Wrap Beauty Devic; Personal Care Device; Facial Care Device LED Red Therapy Light; LED Red Light Therapy Device; LED Red and Infrared Light Therapy Device; Red Light Therapy Panel; Red Light Therapy Cap; LED Light Therapy Mask; LED Therapy Mask; LED Silicone Therapy Mask; LED Light Therapy Panel; Light Therapy Machine; Red Light Therapy Lamp; Red Light Therapy; LED RED Light Mat; LED Facial Therapy Mask; Red Light Therapy Eye Mask Red Light Therapy Belt; Red Light Therapy Sleeping Bag; Red Light Therapy Blanket; LED Red Light Therapy Pad; Red Light Therapy Mat; LED Light Therapy Yoga Mat; Red Light Therapy Knee Pads; Red Light Therapy Wrap;

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	2026-03-19
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2026-03-19
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-03-19

Official Correspondent

Tina Tina

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

SHENZHEN MEIHUI OPTOELECTRONICS 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 3044989687. Last updated year: 2026. Please use registration number 3044989687 when referencing this establishment in official correspondence.