DEVICE: Kardia Mobile (B210AC0090)
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Device Identifier (DI) Information
Kardia Mobile
AC-009
In Commercial Distribution
Alivecor, Inc.
AC-009
In Commercial Distribution
Alivecor, Inc.
KardiaMobile is a personal EKG device that is capable of recording a Single-Lead EKG. It has two electrodes on the top surface and is powered by a replaceable battery located on the back of the device. Ultrasonic transmission is used to wirelessly transmit EKG data from the device to your smartphone or tablet.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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| No | |
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| Yes | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 62641 | Electrocardiograph, home-use |
A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
| DPS | Electrocardiograph |
| QDA | Electrocardiograph Software For Over-The-Counter Use |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
75aa5916-42d0-4689-9034-8ba00824921d
January 09, 2026
5
September 24, 2016
January 09, 2026
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined