Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022077

FEI Number

3000171642

Entity Name

AMG MEDICAL INC.

City/State/Country

MONTREAL Quebec, CA

Establishment Address

8505 DALTON, MONTREAL Quebec H4T 1V5, CA

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

AMG MEDICAL INC. (Owner Number: 8022077)

Owner / Operator Contact Address

8505 DALTON, --, MONTREAL, CA-QC H4T 1V5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173462

PMA Number

N/A

All Registered Proprietary Names

Physio Logic ProScan Non-Contact Infrared Thermometer Physiologic Non-contact Infrared Thermometer Physio Logic Essentia+ BPM (106-930) MedPro Heavy Duty SS IV Pole MedPro Stackable SS IV Pole MedPro Euro Commode MedPro Home Care Commode MedPro Standard Commode MedPro Folding Commode MedPro MGrip Contoured Bedside Rail MedPro Bed Side Rail ProActive Pedal Exerciser Ultra-Blok Underpads 23x36" Ultra-Blok Underpads 17x24" MEDPRO COMPRESSOR NEBULIZER MedPro Bulbous Urinal MedPro Urine Specimen Bowl MedPro Specimen Cup MedPro Graduated Jug MedPro Female Urinal MedPro Male Urinal ProActive ThermOBeads Multiuse Compress ProActive ThermOBeads Back Wrap ProActive ThermOBeads Eye Mask ProActive ThermOBeads Shoulder and Neck ProActive ThermOBeads Knee Wrap ProActive Therm-O-Clay Multi-Purpose Pack MedPro Versa Hot / Cold Pack (740-785) Therm-O-Clay Waterless Cozy Bottle Therm-O-Clay Luxurious Eye Mask PhysioLogic DigiSlim Scale MEDPRO UNDERPAD WHITE AMG PROTECTIVE UNDERWEAR MEDPRO INCONTINENT UNDERPADS AMG Ultra-Absorbent Protective Underwear UltraBlok Quilted Underpad Ultra-Blok Underpad ColorPro Steth Silver Premier Elite 2H Steth ColorPro Sprague-Rappaport Steth ColorPro Dual Steth Silver MedPro DEFENCE - ZORB Commode Liners Standard Commode by AMG Medical Inc. ProActive Alevia 2 in 1 TENS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2016-09-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-12-07
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2010-11-16
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2004-02-05
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2022-08-31
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2004-02-05
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2019-01-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2016-11-07
FNP	Urinal	General Hospital	Class 1	880.6730	2008-02-26
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2006-01-04
FRW	Scale, Patient	General Hospital	Class 1	880.2720	2019-01-15
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2023-10-11
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2004-02-05
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2006-08-22
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2019-01-15
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis	Neurology	Class 2	882.5890	2022-12-09
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2022-12-09
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2022-12-09

Official Correspondent

No official correspondent registered.

US Agent Details

KEVIN WALLS Business: REGULATORY INSIGHT, INC. Email: KEVIN@REGINSIGHT.COM Phone: (720) 9625412

Related Public Records

Same Entity

AMG MEDICAL INC.

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022077. Last updated year: 2026. Please use registration number 8022077 when referencing this establishment in official correspondence.