Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948534

FEI Number

3006948534

Entity Name

XIAMEN COMFORT SCIENCE & TECHNOLOGY GROUP CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

5F, 168# Qianpu Road, Xiamen Fujian 361009, CN

Establishment Type(s)

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

Owner / Operator

Xiamen Comfort Science & Technology Group Co., Ltd. (Owner Number: 10025046)

Owner / Operator Contact Address

#168 Qianpu Road, Xiamen, CN-FJ 361009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SHARPER IMAGE: 1021577,1021578, Neck and Shoulder Wrap SHARPER IMAGE:1014136,1018412, Neck and Shoulder Wrap Heated SHARPER IMAGE:1016927,1017232, Compression Body Wrap Heated SHARPER IMAGE:1016926,Compression Back Wrap Heated SHARPER IMAGE:1016971,1018336, Massager Realtouch Lumbar Acupressure Back SHARPER IMAGE:1017854, Massager Foot Bath Zen SHARPER IMAGE:1014495,1014743,1014397 Massager Foot Bath Heating SHARPER IMAGE:1014508,1015507 Massager Multi-Function Shiatsu Full Body Cordless SHARPER IMAGE:1018016, Massager Foot Bath Zen with Splash Guard

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-12-20
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2024-12-20

Official Correspondent

Amy Chan

US Agent Details

Clare Ho Business: SHARE INFO INC. Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

Xiamen Comfort Science & Technology Group 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948534. Last updated year: 2026. Please use registration number 3006948534 when referencing this establishment in official correspondence.