Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611559

FEI Number

3003255513

Entity Name

LU MARK ENTERPRISES, INC.

City/State/Country

XINWU Dist. Taoyuan, TW

Establishment Address

NO.257, SEC. 2, ZHONGSHAN E. RD, XINWU Dist. Taoyuan 32741, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LU MARK ENTERPRISES, INC. (Owner Number: 9044328)

Owner / Operator Contact Address

XINWU DISTRICT, SEC. 2, ZHONGSHAN E. RD. NO. 257, TAOYUAN, TW-TAO 32741, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Arctic System Aqua relief System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2020-08-12
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2001-01-12
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2018-11-05
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2018-11-05
FZF	Splint, Extremity, Inflatable, External	General, Plastic Surgery	Class 1	878.3900	2014-02-06
IMA	Pack, Heat, Moist	Physical Medicine	Class 1	890.5730	2011-03-29

Official Correspondent

MARK LU

US Agent Details

Ying Hsuan Lu Email: annelu850107@gmail.Com Phone: (949) 4869187

Related Public Records

Same Entity

LU MARK ENTERPRISES, INC.

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 9611559. Last updated year: 2026. Please use registration number 9611559 when referencing this establishment in official correspondence.