EASY HEALTHCARE CORPORATION

FDA Device Registration & Listing · Darien, IL, US · Registration 3012725363

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012725363
FEI Number
3012725363
Entity Name
EASY HEALTHCARE CORPORATION
City/State/Country
Darien, IL, US
Establishment Address
8251 Lemont Rd, Darien, IL 60561, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
EASY HEALTHCARE CORPORATION (Owner Number: 10052041)
Owner / Operator Contact Address
8251 Lemont Road, Darien, IL 60561, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K101387
PMA Number
N/A

All Registered Proprietary Names

EASY@HOME PREGNANCY TEST (EZW1-MD) Easy@Home Blood Pressure Monitor (EBP-020) Sweetiesong Pocket Fetal Doppler (EZD-100S5) Easy@Home Pulse Oximeter (EHP050) Easy@Home Fingertip Pulse Oximeter (EHP029) Sweetiesong Pocket Fetal Doppler (EZD-100ST) Areta Cotinine Test Strip (ASCOT-114C) Easy@Home Cotinine Panel Dip Test (ECOT-114) Easy@Home Cotinine Test Dip Card (ECOT-115) Easy@Home Nicotine Urine Test (ECOT-114) Easy@Home Electronic Pulse Stimulator (EHE015BLE) Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads (ETP015) Easy@Home Foot Massage Mat (EFM-05R) Easy@Home Electronic Pain Relief Stimulator Replacement Pads (ETP019) Easy@Home TENS Pain Relief Device (EHE009) Easy@Home Electronic TENS Pulse Massager (EHE010) Easy@Home Electronic TENS Pulse Stimulator (EHE012PRO) Easy@Home Fingertip Pulse Oximeter (EHP-029) easy@Home TENS AND MUSCLE STIMULATOR (EHE080) Easy@Home One Step FSH Urine Test (EFS1-S) Easy@Home FSH Urine Test (EFS1-MA) Easy@Home Marijuana Test Strip (THC 20), ESTH-215 Areta Drug Test Cup Easy@Home Multi-Drug Urine Test Panel Areta Drug Test Cup (ACDOA-754) Easy@Home Multi-Drug Urine Test Cup Easy@Home Blood Pressure Monitor (EBP-96B) Easy@Home® Urinary Tract Infection Test Strips (EZU-101) Easy@Home Wrist Blood Pressure Monitor (TMB-2085) Easy@Home Wrist Blood Pressure Monitor (EBP-085) Easy@Home Wrist Blood Pressure Monitor (EBP-017) Premom Fertility Lubricant Areta Strep A Swab Test (ARST-100S) Areta Strep A Swab Test (ARST-100) Sweetiesong Pocket Fetal Doppler (EZD-100S6) Sweetiesong Fetal Doppler (EZD-100B) easy@Home Fentanyl Urine Test (Cassette), ECFY-114 Premom Pregnancy Test Strips (PMS1-S) Easy@Home Pregnancy Test Strips (EZW1-S) Easy@Home Pregnancy Test Strip (EZW1-S) Easy@Home Mini Electronic Pulse Stimulator (EHE029G) Easy@Home Wireless TENS Pulse Massager (EHE016) Easy@Home Electronic TENS Pulse Massager (EHE010) Easy@Home Blood Pressure Monitor (EBP-08B) Areta Urinalysis Reagent Strips 100 Tests Areta Urinalysis Reagent Strips 50 Tests Easy@Home PdG Urine Test (EZW3-S) Easy@Home PREGNANCY TEST, EZW1-M Easy@Home Urinary Tract Infection Test (EZU-102) Areta Fingertip Pulse Oximeter (EZD-500A) Easy@Home Blood Pressure Monitor (EBP-095) Easy@Home Non-contact Infrared Thermometer (JXB-178) Easy@Home Non-contact Infrared Thermometer(NCT-301) Easy@Home Blood Pressure Monitor (EBP-20T) Easy@Home Blood Pressure Monitor (EBP-703) Easy@Home Blood Pressure Monitor (EBP-703T) Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (EDTH-114) Easy@Home Fingertip Pulse Oximeter (EHP029) Areta Fingertip Pulse Oximeter (EZD-500A) Easy@Home Fingertip Pulse Oximeter (EHP035) Easy@Home Pulse Oximeter (EHP050) Areta® Multi-Drug Test Cup (ACDOA-254) Areta® Multi-Drug Test Cup (ACDOA-264) Easy@Home® Drug Test Cup ( ECDOA-254) Easy@Home® Drug Test Cup (ECDOA-7124) Areta® Multi-Drug Test Cup (ACDOA-6125B) Easy@Home® Drug Test Cup ( ECDOA3-6125B) Easy@Home® Drug Test Cup ( ECDOA-6125B) Easy@Home® Drug Test Cup ( ECDOA-1144A3) Areta® Multi-Drug Test Cup (ACDOA-1144) Easy@Home TENS/EMS Pulse Stimulator Replacement Pads (ETP510) Easy@Home Self-Adhesive Reusable Electrodes (ETP538) Easy@Home Self-Adhesive Reusable Electrodes (ETP505) Easy@Home Mini Wireless TENS Pulse Stimulator Replacement Pads (ETP015) EASY@HOME ADHESIVE ELECTRODE PADS (ETP015B) Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (EDTH-114) Easy@Home Multi-Drug Screen Test (EDOAP-124) Easy@Home Marijuana Test Strips (ESTH-115) Areta Marijuana Test Strip (ASTH-114C) Easy@Home Marijuana Test Dip Card (EDTH-115) EASY@HOME Marijuana Test Cup (ECTH4-114A3) Easy@Home Pregnancy Test (EZ-MA3S6) Easy@Home Pregnancy Test (EZW1-SC) Easy@Home Pregnancy Test (EZW1-MA) Easy@Home 2-in-1 Lactation Massager (EHL038) Easy@Home Hand Massager (EHM018) Premom Ovulation Test, PMS2-S Easy@Home Ovulation Test,EZW2-S Easy@Home Ovulation Test, EZW2-S Easy@Home Ovulation Test Kit (EZ-WS155) Easy@Home Ovulation Test Kit (EZ-WS4010) Easy@Home Ovulation Test Kit (EZ-WS10020) Easy@Home Ovulation Test Kit (EZ-WS5020) Easy@Home Ovulation Test Kit (EZTB-S-523) Easy@Home Ovulation Test Kit (EZTB-S-520) Premom Quantitative Ovulation Predictor (PMS2-S) Premom Quantitative Ovulaiton Predictor Kit (PMS-4010) Easy@Home Ovulation Test Kit (with Premom® Mobile Application) Easy@Home Ovulation Test Kit (EZ-WS10040) Premom Quantitative Ovulaiton Predictor Kit (PMS-5020) Premom Ovulation Predictor Kit (PMS-4010) Easy@Home Ovulation Test Kit (EZM1-L8H2) Premom Quantitative Ovulaiton Predictor Kit (PMS-105) Premom Quantitative Ovulaiton Predictor Kit (PMS-205) Premom Quantitative Ovulaiton Predictor Kit (PMS-10020) Premom Ovulation Predictor Kit (PMS-255) Premom Quantitative Ovulaiton Predictor Kit (PMS-10040) Easy@Home Ovulation Test Kit (EZ-WS205) Easy@Home Ovulation Test Kit (EZTB-S-521) Easy@Home Ovulation Test Strips (EZW2-S) Premom Quantitative Ovulaiton Predictor Kit (with Premom® Mobile Application) Premom Ovulation Test (PMS2-S) Premom Quantitative Ovulation Predictor Kit (PM2-D) Easy@Home Ovulation Test Premom Ovulation Test Easy@Home Ovulation Test (EZW2-S) Premom Semi-quantitative Ovulation Test Easy@Home® Multi-Drug Screen Test (EDOAP-3104) Easy@Home® Multi-Drug Screen Test (EDOAP-254) Easy@Home® Multi-Drug Screen Test (EDOAP-1124) Easy@Home® Multi-Drug Screen Test (EDOAP-6124) Easy@Home® Multi-Drug Screen Test (EDOAP-654) Easy@Home® Multi-Drug Screen Test (EDOAP-264) Easy@Home® Multi-Drug Screen Test (EDOAP-754) Easy@Home® Multi-Drug Screen Test (EDOAP-7104) Easy@Home® Multi-Drug Screen Test (EDOAP-144) Easy@Home® Multi-Drug Screen Test (EDOAP-6125B) Easy@Home® Multi-Drug Screen Test (EDOAP-4104) Easy@Home® Multi-Drug Screen Test (EDOAP-865) Easy@Home® Multi-Drug Screen Test (WDOA-865) Easy@Home® Multi-Drug Screen Test (EDOAP-065) Easy@Home® Multi-Drug Screen Test (EDOAP-154) Easy@Home® Multi-Drug Screen Test (EDOAP-7125) Easy@Home TENS Electrode Pads (ETP018) Easy@Home Heat TENS Unit (EHE018) Easy@Home Multi-Drug Urine Test Cup Easy@Home Multi-Drug Urine Test Panel Easy@Home Infrared Ear Thermometers (EET-302) Easy@Home Smart Fertility Tracker (EBT-500) Easy@Home Digital Basal Thermometer (EBT-201) Premom Pregnancy Test (PMS1-S, PMS1-M, PM1-M3) Easy@Home Pregnancy Test (EZW1-S, EZW1-M) Easy@Home Visual Baby Nasal Aspirator (ENA101) Easy@Home Baby Nasal Aspirator (ENA102)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-08-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-11-13
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2022-08-12
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2020-11-24
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2020-04-27
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-02-10
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2020-11-24
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-01-17
MRS Test System, Nicotine, Cotinine, Metabolites Clinical Toxicology Class 1 862.3220 2020-03-29
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2018-10-30
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2018-10-30
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2018-10-30
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2018-10-30
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2016-06-12
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2016-06-12
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2021-10-22
DQA Oximeter Cardiovascular Class 2 870.2700 2020-01-16
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2024-10-18
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2024-10-18
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2023-06-06
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2025-04-21
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2016-06-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-07-03
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2018-10-28
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2018-10-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-10-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2016-06-12
PEB Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible Obstetrics/Gynecology Class 2 884.5300 2024-01-12
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2021-08-31
KNG Monitor, Ultrasonic, Fetal Obstetrics/Gynecology Class 2 884.2660 2016-06-12
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-12-20
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2018-12-20
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2023-02-05
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2016-06-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-10-26
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2021-06-25
QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter Clinical Chemistry Class 1 862.1620 2020-11-10
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2026-02-06
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2024-05-07
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2024-05-07
DQA Oximeter Cardiovascular Class 2 870.2700 2016-06-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2019-01-17
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-06-13
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-06-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-06-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2024-12-02
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2021-07-01
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2016-06-12
JXN Enzyme Immunoassay, Propoxyphene Clinical Toxicology Class 2 862.3700 2016-06-12
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2020-04-27
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2020-11-22
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2020-11-22
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2020-11-22
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2020-11-22
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2020-11-22
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2020-11-22
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2020-11-22
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2020-11-22
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2020-11-22
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2020-11-22
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2020-11-22
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2016-06-12
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2019-04-01
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-04-01
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2019-04-01
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-01-16
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2022-06-08
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2016-06-12
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2021-10-28
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2021-10-28
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2021-10-28
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2021-10-28
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2021-10-28
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2021-10-28
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2021-10-28
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2021-10-28
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2021-10-28
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2021-10-28
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2021-10-28
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology Class 2 882.5890 2021-06-08
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2021-06-08
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2021-06-08
NYN Stimulator, Electrical, Transcutaneous, For Arthritis Neurology Class 2 882.5890 2021-06-08
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2016-06-12
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2016-06-12
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2016-06-12
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2016-06-12
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2016-06-12
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2016-06-12
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2016-06-12
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2016-06-12
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2016-06-12
LHD Device, Fertility Diagnostic, Proceptive Unknown Class U N/A 2016-10-18
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-11-21
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2018-12-13
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2022-09-14
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-03-31

Official Correspondent

XIAOLIAN LIU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EASY HEALTHCARE CORPORATION
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
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
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.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012725363. Last updated year: 2026. Please use registration number 3012725363 when referencing this establishment in official correspondence.
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