Data / Medical devices / Canada / HOMEDICS Group Canada

HOMEDICS Group Canada: FDA-registered device maker in Mississauga Ontario, Canada, 8 510(k) clearances

Name: HOMEDICS Group Canada FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

HOMEDICS Group Canada is registered with the FDA (registration 3008011951) in Mississauga Ontario, Canada. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 12, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008011951
Address: 6460 Kennedy Road, Unit C, Mississauga Ontario, Canada, L5T 2X4
Owner or operator: Homedics Group Canada (10043839)
Roles: Repackager or relabeler
First device listed: April 1, 2013
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Repackager or relabeler	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	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
June 12, 2020	K200521	Full Automatic(NIBP) Blood Pressure Monitor	DXN	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov
September 16, 2019	K190507	Full Automatic (NIBP) Blood Pressure Monitor	DXN	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov
July 6, 2016	K160557	Full Automatic (NIBP) Blood Pressure Monitor	DXN	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov
March 19, 2012	K112392	HIVOX BIOTEK INC.	NUH	Substantially Equivalent	Hivox Biotek, Inc.	accessdata.fda.gov
March 25, 2010	K093831	FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT	DXN	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov
February 16, 2010	K093824	FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL158BT	DXN	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov
June 24, 2008	K081160	AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES	FLL	Substantially Equivalent	Avita Corporation	accessdata.fda.gov
March 31, 2005	K050491	H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF	DXN	Substantially Equivalent	Health & Life Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated June 12, 2020. 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.