Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003803075

FEI Number

3003803075

Entity Name

EMG TECHNOLOGY CO., LTD.

City/State/Country

Taichung City, TW

Establishment Address

5F,4F.,No.3,Jingke 5th Rd., Nantun Dist.,, Taichung City 40852, TW

Establishment Type(s)

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

Owner / Operator

EMG TECHNOLOGY CO., LTD. (Owner Number: 9050909)

Owner / Operator Contact Address

5F,4F.,No.3,Jingke 5th Rd., Nantun Dist., Taichung City, TW-TXG 40852, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112421

PMA Number

N/A

All Registered Proprietary Names

50PSI AIR COMPRESSOR EMG EMG QUADRANT TOURNIQUET MDT EMG EMG MDT EMG MDT EMG EMG Suction Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2022-12-23
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2008-05-02
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-11-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-04-11
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2007-04-11
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-04-11
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2007-12-20
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2011-09-17

Official Correspondent

Jason Huang

US Agent Details

Frederick Kiwak Email: fkiwak@goldentech.com Phone: (570) 6553700

Related Public Records

Same Entity

EMG 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
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

Similar Registrations

Registration Number	Establishment Name	Location
3008496560	NINGBO GREETMED MEDICAL INSTRUMENTS CO., LTD.	Ningbo Zhejiang, CN
3007238566	BEIJING AEONMED CO., LTD.	Sanhe Hebei, CN
3012336822	GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.	Foshan Guangdong, CN
2515872	DeVilbiss Healthcare LLC.	SOMERSET, PA, US
2028807	WESTMED, INC.	TUCSON, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003803075. Last updated year: 2026. Please use registration number 3003803075 when referencing this establishment in official correspondence.