ELEFT (Eko Low Ejection Fraction Tool)

Primary DI
00850010298146
Brand
ELEFT (Eko Low Ejection Fraction Tool)
Company
Eko Devices, Inc.
Model
v7.x
Catalog number
ELEFT
Device description
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Published
2025-03-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QYEReduced Ejection Fraction Machine Learning-Based Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYEReduced Ejection Fraction Machine Learning-Based Notification SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233409000Eko Low Ejection Fraction Tool (ELEFT)Eko Health, Inc.2024-03-28QYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010298146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010298146008500102981468500102981460850010298146

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis softwareA software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079670921
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkE8CAC500_FRP2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyE8CAC500_FOT2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceE8COR500_ROG2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceE8CAC500_ROG2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGE8COR503-ROG/ROG2026-04-03
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueE8CAC500_FCB2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)1.x.xEFAST2026-01-29
00850010298184EMAS (Eko Murmur Analysis Software) Version 1.xEMAS2025-03-17
00850010298030Eko Analysis SoftwareEAS2020-09-08
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceE8COR500_CBL2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceE8CAC500_CBL2025-11-07
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceE8COR500_RED2025-10-15
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryE8CAC500_FEL2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteE8CAC500_FOW2025-10-15
00850010298726CORE 500 Digital Stethoscope - Electric Pink ChestpieceE8COR500_PNK2025-08-12
00850010298757CORE 500 Digital Stethoscope - Electric Pink EarpieceE8CAC500_PNK2025-08-12
00850010298788CORE 500 Digital Stethoscope - Bundle-SLVE8COR503-SLV/SLV2025-08-12
00850010298795CORE 500 Digital Stethoscope - Bundle-BLKE8COR503-BLK/BLK2025-08-12
00850010298801CORE 500 Digital Stethoscope - Bundle-CHPE8COR503-CHP/CHP2025-08-12
00850010298818CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club PinkE8CAC500_FMG2025-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013616823ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithmAnumana, Inc.QYE2026-03-20
00860011843610Tempus ECG-Low EFTempus AI, Inc.QYE2025-07-24
00860007426445ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithmAnumana, Inc.QYE2024-12-05
00860007426407ECG-AI LEF 12-Lead AlgorithmAnumana, Inc.QYE2024-01-15