Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014144875

FEI Number

3014144875

Entity Name

POWER WELL HEALTHCARE TECHNOLOGY CO., LTD.

City/State/Country

Changhua County, TW

Establishment Address

No.26, Lane 222, Lunzijiao Road, Xihu Township, Changhua County 514, TW

Establishment Type(s)

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

Owner / Operator

Power Well Healthcare Technology Co., Ltd. (Owner Number: 10056225)

Owner / Operator Contact Address

No.26, Lane 222, Lunzijiao Road, Xihu Township, Changhua County, TW-CHA 514, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pelvic Support Powered Heating Pad Temporary Training Splint Face Mask (Except N95 Respirator) Hernia Support Lumbar Orthosis Face Mask (Except N95 Respirator) Breast Binder Cervical Support Abdominal Binder Arm Support Limb and Elbow Binder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2017-11-16
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2017-11-16
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2017-11-16
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2017-11-16
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2017-11-16
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-11-16
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-08-17
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2017-11-16
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2017-11-16
FSD	Binder, Abdominal	General Hospital	Class 1	880.5160	2017-11-16
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2017-11-16
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2017-11-16

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Power Well Healthcare 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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014144875. Last updated year: 2026. Please use registration number 3014144875 when referencing this establishment in official correspondence.