Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008381219

FEI Number

3008381219

Entity Name

Sun Polar International Co., Ltd.

City/State/Country

Changhua County, TW

Establishment Address

No. 3-68, Wanfeng Ln., Fuxing Township, Changhua County 506010, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sun Polar International Co., Ltd. (Owner Number: 9093721)

Owner / Operator Contact Address

No. 3-68, Wanfeng Ln., Fuxing Township, Changhua County, TW-CHA 506010, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arm Support Medical Stocking Elastic Bandage Limb Brace Ankle Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-07-11
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2013-03-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-11-26
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2014-02-17
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2013-03-21

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

Sun Polar International Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008381219. Last updated year: 2026. Please use registration number 3008381219 when referencing this establishment in official correspondence.