HeartBeam ECG System

Primary DI
00850048674028
Brand
HeartBeam ECG System
Company
HeartBeam, Inc.
Model
5002A
Catalog number
5002A
Device description
The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3 lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGo™ System is provided by prescription only.
Published
2026-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DXHTransmitters And Receivers, Electrocardiograph, Telephone
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250258000HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.2025-12-08DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048674028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048674028008500486740288500486740280850048674028

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographic, telemetricA small unit dedicated for the receipt of wireless electrocardiogram (ECG) signals sent from an ambulatory patient so that the electrical activity of the patient's heart can be monitored when the patient is remote to the patient monitoring system. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG signal information received and provided by this module.

Regulatory Flags#

DUNS number
069464049
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Primary DI, Brand, Company table
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