Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010839093

FEI Number

3010839093

Entity Name

EMS SURPLUS CANADA

City/State/Country

Sombra Ontario, CA

Establishment Address

2811 St Clair Parkway, Sombra Ontario N0P 2H0, CA

Establishment Type(s)

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

Owner / Operator

EMS SURPLUS CANADA (Owner Number: 10051308)

Owner / Operator Contact Address

2811 St Clair Parkway, Sombra, CA-ON N0P 2H0, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133269

PMA Number

N/A

All Registered Proprietary Names

Stryker LP15 defibrillator Zoll X series Defibrillator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2016-03-01
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-11-13

Official Correspondent

Kenneth MacEachern

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

EMS SURPLUS CANADA

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-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Similar Registrations

Registration Number	Establishment Name	Location
2112020	ZOLL Medical Corporation	DEERFIELD, WI, US
3010030355	PHYSIO-CONTROL MAASTRICHT, INC.	Maastricht Limburg, NL
3029871637	ZOLL International Holding B.V.	Elst Gelderland, NL
3015876	PHYSIO-CONTROL, INC.	Redmond, WA, US
3017422354	EMI (DONGGUAN) ASIA LIMITED	Dongguan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010839093. Last updated year: 2026. Please use registration number 3010839093 when referencing this establishment in official correspondence.