Data / Medical devices / United States / Easy Healthcare Corporation

Easy Healthcare Corporation: FDA-registered device maker in Darien, IL, United States, 58 510(k) clearances

Name: Easy Healthcare Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Easy Healthcare Corporation is registered with the FDA (registration 3012725363) in Darien, IL, United States. It lists 53 device types. The FDA files 58 510(k) clearances under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Easy Healthcare Corporation

FDA registration number: 3012725363
Address: 8251 Lemont Rd, Darien, IL, United States, 60561
Owner or operator: EASY HEALTHCARE CORPORATION (10052041)
Roles: Repackager or relabeler
First device listed: June 12, 2016
Registered through: 2026
Brand names listed: Areta Cocaine Test Strip (ASCOC-114), Areta Cotinine Test Strip (ASCOT-114C), Areta Drug Test Cup, Areta Drug Test Cup (ACDOA-754), Areta Fingertip Pulse Oximeter (EZD-500A), Areta Marijuana Test Strip (ASTH-114C), Areta Multi-Drug Screen Test (ADTP-1124), Areta Multi-Drug Screen Test (ADTP-254) and more

Devices it lists

Device	Product code	Class	Role	Source
Antigens, All Groups, Streptococcus Spp.	GTY	1	Repackager or relabeler	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Repackager or relabeler	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Device, Fertility Diagnostic, Proceptive	LHD	U	Repackager or relabeler	accessdata.fda.gov
Devices, Breath Trapping, Alcohol	DJZ	1	Repackager or relabeler	accessdata.fda.gov
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	1	Repackager or relabeler	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Amphetamine	DKZ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Barbiturate	DIS	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Benzodiazepine	JXM	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cannabinoids	LDJ	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Opiates	DJG	2	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Phencyclidine	LCM	U	Repackager or relabeler	accessdata.fda.gov
Enzyme Immunoassay, Propoxyphene	JXN	2	Repackager or relabeler	accessdata.fda.gov
Gas Chromatography, Methamphetamine	LAF	2	Repackager or relabeler	accessdata.fda.gov
Immunoassay, Pregnanediol Glucuronide, Over The Counter	QKE	1	Repackager or relabeler	accessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	2	Repackager or relabeler	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Repackager or relabeler	accessdata.fda.gov
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible	PEB	2	Repackager or relabeler	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Monitor, Ultrasonic, Fetal	KNG	2	Repackager or relabeler	accessdata.fda.gov
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	1	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Repackager or relabeler	accessdata.fda.gov
Oximeter, Wellness	PGJ	2	Repackager or relabeler	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Repackager or relabeler	accessdata.fda.gov
Paper, Obstetric Ph	LNW	1	Repackager or relabeler	accessdata.fda.gov
Spectrophotometric Method, Pregnanediol	JLP	1	Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Transcutaneous, For Arthritis	NYN	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	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
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	accessdata.fda.gov
Test System, Nicotine, Cotinine, Metabolites	MRS	1	Repackager or relabeler	accessdata.fda.gov
Test, Amphetamine, Over The Counter	NFT	2	Repackager or relabeler	accessdata.fda.gov
Test, Barbiturate, Over The Counter	PTH	2	Repackager or relabeler	accessdata.fda.gov
Test, Benzodiazepine, Over The Counter	NFV	2	Repackager or relabeler	accessdata.fda.gov
Test, Cannabinoid, Over The Counter	NFW	2	Repackager or relabeler	accessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	2	Repackager or relabeler	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Repackager or relabeler	accessdata.fda.gov
Test, Luteinizing Hormone (Lh), Over The Counter	NGE	1	Repackager or relabeler	accessdata.fda.gov
Test, Methadone, Over The Counter	PTG	2	Repackager or relabeler	accessdata.fda.gov
Test, Methamphetamine, Over The Counter	NGG	2	Repackager or relabeler	accessdata.fda.gov
Test, Opiates, Over The Counter	NGL	2	Repackager or relabeler	accessdata.fda.gov
Test, Phencyclidine (Pcp), Over The Counter	NGM	U	Repackager or relabeler	accessdata.fda.gov
Test, Propoxyphene, Over The Counter	QBF	2	Repackager or relabeler	accessdata.fda.gov
Test, Tricyclic Antidepressants, Over The Counter	QAW	2	Repackager or relabeler	accessdata.fda.gov
Test, Urine Leukocyte	LJX	1	Repackager or relabeler	accessdata.fda.gov
Thin Layer Chromatography, Methamphetamine	DJC	2	Repackager or relabeler	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Repackager or relabeler	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	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
August 21, 2024	K241351	Blood Pressure Monitor (TMB-2092-G)	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
June 21, 2024	K240643	MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream	LCX	Substantially Equivalent	Guangzhou Decheng Biotechnology Co., Ltd.	accessdata.fda.gov
May 31, 2024	K240254	Blood Pressure Monitor (TMB-2296-BT)	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
March 19, 2024	K233146	Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Jamr Technology Co., Ltd.	accessdata.fda.gov
March 6, 2024	K240351	FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)	NGL	Substantially Equivalent	Assure Tech., LLC	accessdata.fda.gov
February 5, 2024	K233174	FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream	LCX	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
January 17, 2024	K232732	Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50	LDJ	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
June 16, 2023	K231045	Healgen URS Test Strips	LJX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
February 28, 2023	K230038	MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)	LCX	Substantially Equivalent	Guangzhou Decheng Biotechnology Co., Ltd.	accessdata.fda.gov
August 29, 2022	K212248	GlucoLeader Enhance 2 Blood Glucose Monitoring System	NBW	Substantially Equivalent	Hmd Biomedical, Inc.	accessdata.fda.gov
June 30, 2022	K212418	hCG One Step Pregnancy Test	LCX	Substantially Equivalent	Healstone Biotech, Inc.	accessdata.fda.gov
April 5, 2022	K213808	Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream	LCX	Substantially Equivalent	Co-Innovation Biotech Co., Ltd.	accessdata.fda.gov
February 9, 2022	K212705	Actively Trying Personal Lubricant Unfragrance	PEB	Substantially Equivalent	CC Wellness, LLC	accessdata.fda.gov
January 5, 2022	K212115	Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor	DXN	Substantially Equivalent	Joytech Healthcare Co. , Ltd.	accessdata.fda.gov
September 25, 2020	K202567	Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
July 1, 2020	K200561	StimPlus Patch, StimPlus Patch, StimPlus Patch	NUH	Substantially Equivalent	Jkh Health Co., Ltd.	accessdata.fda.gov
June 18, 2020	K200727	TENS and Muscle Stimulator	NUH	Substantially Equivalent	Shenzhen Astec Technology Co., Ltd.	accessdata.fda.gov
November 22, 2019	K192843	INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream	LCX	Substantially Equivalent	Innovita (Tangshan) Biological Technology Co., Ltd.	accessdata.fda.gov
November 18, 2019	K183393	Digital Thermometer	FLL	Substantially Equivalent	Joytech Healthcare Co. , Ltd.	accessdata.fda.gov
May 8, 2019	K182428	GlucoLeader Enhance Blood Glucose Monitoring System	NBW	Substantially Equivalent	Hmd Biomedical, Inc.	accessdata.fda.gov
March 3, 2019	K182495	Electronic Blood Pressure Monitor	DXN	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
December 3, 2018	K182701	Wondfo T-Cup Multi-Drug Urine Test Cup	NFT	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
April 5, 2018	K180349	AssureTech Panel Dip Tests, AssureTech Quick Cup Tests	NFT	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
September 19, 2017	K163518	Digital Thermometer	FLL	Substantially Equivalent	Joytech Healthcare Co. , Ltd.	accessdata.fda.gov
July 6, 2017	K170587	On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis	JIN	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
April 14, 2017	K162517	Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13	NUH	Substantially Equivalent	Jkh Health Co., Ltd.	accessdata.fda.gov
October 5, 2016	K161560	Fingertip Pulse Oximeter MD300CN310	DQA	Substantially Equivalent	Beijing Choice Electronic Technology Co., Ltd.	accessdata.fda.gov
July 15, 2016	K160308	Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)	FLL	Substantially Equivalent	Fudakang Industrial Co., Ltd.	accessdata.fda.gov
July 6, 2016	K161044	AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)	DJC	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
May 27, 2016	K153149	Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
May 5, 2016	K153520	Electronic Pulse Stimulator	NUH	Substantially Equivalent	Jkh Health Co., Ltd.	accessdata.fda.gov
March 31, 2016	K153465	AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)	DKZ	Substantially Equivalent	Assure Tech. (Hangzhou) Co, Ltd.	accessdata.fda.gov
March 31, 2016	K153146	Infrared Ear Thermometer	FLL	Substantially Equivalent	Sejoy Electronics & Instruments Co., Ltd.	accessdata.fda.gov
July 21, 2015	K143268	TENS AND POWERED MUSCLE STIMULATOR	NUH	Substantially Equivalent	Shenzhen As-Tec Technology Co., Ltd.	accessdata.fda.gov
September 17, 2014	K141260	ELECTRONIC PULSE STIMULATOR	NUH	Substantially Equivalent	Shenzhen Jingkehui Electronic Co.., Ltd.	accessdata.fda.gov
August 28, 2014	K140582	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
February 25, 2014	K133968	WONDFO MULTI-DRUG URINE TEST CUP, PANEL	DKZ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
January 24, 2014	K131457	FETAL ULTRASONIC MONITOR AND ACCESSORIES	KNG	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
November 22, 2013	K132588	ADHESIVE ELECTRODES	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
November 15, 2013	K131921	ELECTRONIC PULSE STIMULATOR	NUH	Substantially Equivalent	Shenzhen Jingkehui Electronic Co.., Ltd.	accessdata.fda.gov
October 15, 2013	K130231	NON-CONTACT INFRARED THERMOMETER	FLL	Substantially Equivalent	Jinxinbao Electronic Co.,Ltd	accessdata.fda.gov
June 19, 2013	K131395	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
April 10, 2013	K123703	HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)	LCX	Substantially Equivalent	Healgen Scientific,, LLC	accessdata.fda.gov
April 9, 2013	K130665	WONDOFO MULTI-DRUG URINE TEST CUP / PANEL	DJG	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
December 21, 2012	K123669	TRANSTEK WRIST BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
November 7, 2012	K122912	DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)	FLL	Substantially Equivalent	Hangzhou Hua'An Medical & Health Instruments Co.,	accessdata.fda.gov
October 22, 2012	K122482	TRANSTEK WRIST BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
July 25, 2012	K121557	WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST	LDJ	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov
January 31, 2012	K120058	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
July 28, 2011	K103574	PREGNANCY ONE STEP RAPID TEST	LCX	Substantially Equivalent	Lehnus & Associates Consulting	accessdata.fda.gov
May 27, 2011	K101681	TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995	DXN	Substantially Equivalent	Zhongshan Transtek Electronics Co., Ltd.	accessdata.fda.gov
February 4, 2011	K110124	FETAL DOPPLER JPD-100S	KNG	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
August 3, 2010	K101387	DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN	FLL	Substantially Equivalent	Fudakang Industries Co., Ltd.	accessdata.fda.gov
February 25, 2009	K082480	CONTEC POCKET FETAL DOPPLER	KNG	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
November 10, 2008	K082641	FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL	DQA	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
November 1, 2007	K072641	DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.	FLL	Substantially Equivalent	Famidoc Technology Co., Ltd.	accessdata.fda.gov
October 12, 2007	K063295	ACON UTI URINARY TRACT INFECTION TEST STRIPS	LJX	Substantially Equivalent	ACON Laboratories, Inc.	accessdata.fda.gov
April 8, 2005	K043443	ONE STEP HCG URINE PREGNANCY TEST	LCX	Substantially Equivalent	Guangzhou Wondfo Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 21, 2024. 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.