ELEFT (Eko Low Ejection Fraction Tool) ELEFT

GUDID 00850010298146

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.

Eko Devices, Inc.

Cardiopulmonary physiological parameter analysis software

• Primary Device ID: 00850010298146
• NIH Device Record Key: d18fd172-b9ae-4813-8c93-c54cc68b11d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELEFT (Eko Low Ejection Fraction Tool)
• Version Model Number: v7.x
• Catalog Number: ELEFT
• Company DUNS: 079670921
• Company Name: Eko Devices, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850010298146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233409

FDA Product Code

• QYE: Reduced Ejection Fraction Machine Learning-Based Notification Software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-25
• Device Publish Date: 2025-03-17

Devices Manufactured by Eko Devices, Inc.

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• 00850010298788 - CORE 500 Digital Stethoscope - Bundle-SLV: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-SLV
• 00850010298795 - CORE 500 Digital Stethoscope - Bundle-BLK: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-BLK
• 00850010298801 - CORE 500 Digital Stethoscope - Bundle-CHP: 2025-08-20 CORE 500 Digital Stethoscope - Bundle-CHP
• 00850010298818 - CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink: 2025-08-20 CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink
• 00850010298733 - CORE 500 Digital Stethoscope - Ruby Earpiece: 2025-03-27 CORE 500 Digital Stethoscope - Ruby Earpiece
• 00850010298245 - CORE 500 Digital Stethoscope FIGS Earpiece - Black: 2025-03-26 CORE 500 Digital Stethoscope FIGS Earpiece - Black