Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010805625

FEI Number

3010805625

Entity Name

ZHEJIANG LUMENG HEALTH & TECHNOLOGY CO.,LTD SHAO XING PAO JIANG BRANCH

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

No.356 Yue Wang Road, Shaoxing Zhejiang 312000, CN

Establishment Type(s)

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

Owner / Operator

ZHEJIANG LUMENG HEALTH & TECHNOLOGY CO.,LTD SHAO XING PAO JI (Owner Number: 10046261)

Owner / Operator Contact Address

No.356 Yue Wang Road, Shaoxing, CN-ZJ 312000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Calming Heat Weighted Heating and Massaging Pad Calming Heat Weighted Heating Pad Calming Heat massaging weighted heating pad with jade stones Calming heat Neck Wrap Calming heat Flexi Wrap Calming heat Knee Wrap calming cozy CALMING HEAT SAUNA 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	2014-02-25

Official Correspondent

Haoyang Zhang

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

ZHEJIANG LUMENG HEALTH & TECHNOLOGY CO.,LTD SHAO XING PAO JI

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

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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 3010805625. Last updated year: 2026. Please use registration number 3010805625 when referencing this establishment in official correspondence.