Data / Medical devices / Taiwan / Emg Technology Co., Ltd.

Emg Technology Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 7 510(k) clearances

Name: Emg Technology Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Emg Technology Co., Ltd. is registered with the FDA (registration 3003803075) in Taichung City, Taiwan. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 1, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003803075
Address: 5F,4F.,No.3,Jingke 5th Rd., Nantun Dist., Taichung City, Taiwan, 40852
Owner or operator: EMG TECHNOLOGY CO., LTD. (9050909)
Roles: Exporter to the US, Manufacturer
First device listed: April 11, 2007
Registered through: 2026
Brand names listed: 50PSI AIR COMPRESSOR, BOTTLE, COLLECTION, VACUUM, EMG, EMG QUADRANT TOURNIQUET, EMG Suction Unit, EMG TRITON-COMP Air Copressor, MDT, Suction Canister

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Suction, Ward Use, Portable, Ac-Powered	JCX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 1, 2011	K112421	EMG SUCTION UNIT	JCX	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
November 19, 2008	K072634	EMG TRITON -COMP,MODEL NCA01-XXX SERIES	BTI	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
November 30, 2006	K063448	EMG AC/DC SUCTION UNIT	JCX	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
January 31, 2006	K052438	EMG HANDLE NEBULIZER NB02 SERIES	CAF	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
October 21, 2005	K043520	EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR	CAW	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
July 6, 2005	K043238	COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES	CAF	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov
December 16, 2004	K042349	EMG MODEL SUA01 SUCTION UNIT	JCX	Substantially Equivalent	Emg Technology Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 3, 2014	68997	Class II	Terminated	Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population f	suction canister lids may have occluded ports.	accessdata.fda.gov

Compare with other makers

Updated September 13, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.