Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011556461

FEI Number

3011556461

Entity Name

COMFORT PLUS CORPORATION

City/State/Country

New Taipei City, TW

Establishment Address

11F., No. 123-9, Xingde Rd., Sanchong District, New Taipei City 24158, TW

Establishment Type(s)

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

Owner / Operator

COMFORT PLUS CORPORATION (Owner Number: 10050248)

Owner / Operator Contact Address

11F., No. 123-9, Xingde Rd., Sanchong District, New Taipei City, TW-TPE 24158, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cervical Orthosis Sacroiliac Orthosis Lumbar Orthosis Ankle Brace Hand Splint Knee Brace Limb Brace Compression Dressing Prevent Pooling of Blood Stocking Maternity Compression Socks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2015-10-26
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2015-10-26
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-10-26
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2015-10-26
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2015-10-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-10-26
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2015-10-26
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2015-10-26

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

COMFORT PLUS CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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

Similar Registrations

Registration Number	Establishment Name	Location
3031583032	NINGBO LANDING TECHNOLOGY COMPANY CO., LTD.	Ningbo Zhejiang, CN
2242467	HAUSMANN ENTERPRISES, LLC	NORTHVALE, NJ, US
3008261717	XIAMEN COMPOWER MEDICAL TECH. CO., LTD.	Xiamen Fujian, CN
3010260768	VTS ONE MEMBER CO., Ltd.	Hai Phong City, VN
3017297225	BSN Medical GmbH	Hamburg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011556461. Last updated year: 2026. Please use registration number 3011556461 when referencing this establishment in official correspondence.