FDA.reportPublic FDA data

KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+

Primary DI
B210AC0190
Brand
KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L+
Company
Alivecor, Inc.
Model
AC-019
Device description
KardiaMobile 6L System is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with your doctor. Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms). The KardiaMobile 6L System hardware has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet.
Published
2020-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DXHTransmitters And Receivers, Electrocardiograph, Telephone
QDAElectrocardiograph Software For Over-The-Counter Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2
QDAElectrocardiograph Software For Over-The-Counter UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183319000Triangle SystemAliveCor, Inc.2019-05-10DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B210AC0190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, single-channelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel) but may otherwise include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included. It is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(855) 338 8800support@alivecor.com
+4403333010433support@alivecor.com

Regulatory Flags#

DUNS number
078523613
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B210AC0290K1000AC-0292025-03-18
B210AC0210KardiaMobile CardAC-0212022-07-13
B210AC0090Kardia MobileAC-0092016-09-24
B210AC0110KardiaBand SystemAC-0112024-03-22
B210AC0270Kardia 12LAC-0272024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DPS2026-06-03
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DPS2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23