Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013601329

FEI Number

3013601329

Entity Name

Hangzhou Wellbeing Technology Co., Ltd.

City/State/Country

Hangzhou City Zhejiang, CN

Establishment Address

318# Songxi Street, Xindeng Town, Fuyang Area, Hangzhou City Zhejiang 311404, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Hangzhou Wellbeing Technology Co., Ltd. (Owner Number: 10053980)

Owner / Operator Contact Address

318# Songxi Street, Xindeng Town, Fuyang Area, Hangzhou City, CN-ZJ 311404, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Face Mask SHARPER IMAGE, 1019348, Steam Sauna Tent and Red Light Eye Pillow Generic Hot/Cold Weighted Neck Wrap Therapy Wrap Hot and Cold Neck and Shoulder Wrap Mint Pillow Eye Mask Hot and Cold Pain Relief Socks COMPOSITE Neck and Shoulder Wrap Heated Eye Mask Weighted EYE MASK MULIT-USE WARP Sharper Image: 1012654,1017191,1012070,1016134,1018018,1019737,1018239, Eye Mask Weighted Sharper Image: 1012287,1011852,1011827,1015498,1011854,1009822,1011853,1010766,1013539,1014961,1015243,1017339,1012549,1017339 Neck and Shoulder Wrap Sharper Image Eye Mask Weighted Hot and Cold Sharper Image:1014136,1016287,1018431,1019665 Neck and Shoulder Wrap Heated Sharper Image:1018432,1018434,1018438,1018433,1018435,1018562,1018439,1018436,1018440,1018437,1015078,1018561,1019662,1019783, Neck and Shoulder Wrap Sharper Image: 1018387 Neck and Shoulder Wrap Unscented SHARPER IMAGE, 1019086,Vest Heated Luxe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-09
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-05-28
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2018-04-24
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2017-01-28
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Hangzhou Wellbeing 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
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013601329. Last updated year: 2026. Please use registration number 3013601329 when referencing this establishment in official correspondence.