KardiaRx
Medical
Free
KardiaRx is a prescription-only clinical application used under the direct supervision of licensed healthcare providers for remote cardiac monitoring and clinical trials. A connection code provided by a licensed healthcare professional is the only way to access KardiaRx. It integrates with the FDA-cleared KardiaMobile 6L hardware to record and transmit 6-lead EKGs to certified technicians and physicians for professional analysis. KardiaRx is not a direct-to-consumer application and does not provide automated self-diagnosis; all medical decisions and interpretations are strictly managed by the licensed healthcare providers.
KardiaRx requires a KardiaMobile 6L device and a connection code to record an EKG. Always consult with your physician before making any medical decision, including altering your use of any drug or treatment.
This application acts as a software component / companion to a regulated medical device. In strict compliance with international medical device regulations, global distribution is restricted exclusively to the twenty-five (25) countries where this device has received formal regulatory clearance or authorization.
KardiaRx is available for download in Australia, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Malaysia, Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States
Updated "About" screen, bug fixes, Auto logout feature and general performance improvements.
The developer, AliveCor, Inc., indicated that the app’s privacy practices may include handling of data as described below. For more information, see the developer’s privacy policy .
Data Not Linked to You
The following data may be collected but it is not linked to your identity:
- Identifiers
- Usage Data
- Diagnostics
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
Information
- Seller
- AliveCor, Inc.
- Size
- 149.5 MB
- Category
- Medical
- Compatibility
Requires iOS 15.8 or later.
- iPhone
Requires iOS 15.8 or later. - iPad
Requires iPadOS 15.8 or later. - iPod touch
Requires iOS 15.8 or later. - Apple Vision
Requires visionOS 1.0 or later.
- iPhone
- Languages
English and 29 more
- English, Arabic, Bulgarian, Croatian, Czech, Danish, Dutch, Finnish, French, German, Greek, Hungarian, Italian, Japanese, Korean, Lithuanian, Malay, Norwegian Bokmål, Polish, Portuguese, Romanian, Russian, Serbian, Simplified Chinese, Slovak, Spanish, Swedish, Tamil, Traditional Chinese, Vietnamese
- Age Rating
16+
- 16+
- Frequent
Medical Treatment information
Contains
Health or Wellness Topics
- Medical Device
Yes
- AliveCor, Inc. indicated this app is a regulated medical device and complies with United States law.
- The information below has not been verified by Apple.
- FDA Owner/Operator Number
- 3009715978
- Address
- 189 Bernardo Ave Ste 100
Mountain View California 94043
United States - Phone Number
- +1 650-257-9950
- alivecor_appleent007@alivecor.com
- Use Statement
- The KardiaMobile 6L System is intended to record, store and transfer one- and two-channel
electrocardiogram (EKG) rhythms. In single channel mode, the KardiaMobile 6L System can
record Lead-I. In two channel mode, the KardiaMobile 6L System can record Lead-I and Lead-II
simultaneously and derive Lead-III and unipolar limb leads aVR, aVF and aVL. The
KardiaMobile 6L System also displays EKG rhythms and output of EKG analysis from AliveCor’s
KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation,
bradycardia, tachycardia, and others. The KardiaMobile 6L System is intended for use by
healthcare professionals, patients with known or suspected heart conditions and health
conscious individuals. The device has not been tested and is not intended for pediatric use - Safety Information
- Contraindications
There are no known contraindications.
Warnings
1. AliveCor does not guarantee that you are not experiencing an arrhythmia or other health
conditions with any EKG result, including normal. You should notify your physician for
possible changes in your health. DO use this device to record heart rate and heart rhythm
only.
2. DO NOT use to diagnose heart-related conditions.
3. DO NOT use to self diagnose heart related conditions. Consult with your physician before‐
making any medical decision, including altering your use of any drug or treatment.
4. DO NOT continue use until further instructed by a physician if your skin is irritated or
inflamed around the electrode.
5. AliveCor makes no warranty for any data or information that is collected erroneously by the
device, or misuse or malfunction as a result of abuse, accidents, alteration, misuse, neglect,
or failure to maintain the products as instructed. Interpretations made by this device are
potential findings, not a complete diagnosis of cardiac conditions. All interpretations should
be reviewed by a medical professional for clinical decision-making.
6. The device has not been tested for and is not intended for pediatric use.
7. Keep device away from young children. Contents may be harmful if swallowed. Device
contains a coin cell battery that is not accessible during normal use but, if exposed, can be a
choking hazard and may cause severe tissue injury if ingested.
8. DO NOT replace the battery when device is in use.
9. DO NOT use the electrode on a portion of the body with too much body fat, body hair or
very dry skin, as a successful recording may not be possible.
10. DO NOT take a recording while driving or during physical activity.
11. DO NOT store in extremely hot, cold, humid, wet, or bright conditions.
12. DO NOT take a recording if electrodes are dirty. Clean them first.
13. DO NOT use alcohol-based or abrasive cleaners and materials as these products could
adversely affect product performance.
14. DO NOT immerse device or expose device to excessive liquid.
15. DO NOT use while charging your phone. If the device is attached to your phone remove it
prior to wireless charging the phone. DO NOT place the device on top of your phone while
wirelessly charging the phone.
16. DO NOT drop or bump with excessive force.
17. DO NOT expose to strong electromagnetic fields.
18. DO NOT expose the device to a magnetic resonance (MR) environment.
19. DO NOT use with a cardiac pacemaker, ICDs, or other implanted electronic devices.
20. DO NOT use during cautery and external defibrillation procedures.
21. DO NOT place electrodes in contact with other conductive parts including earth.
22. DO NOT use with un-approved accessories. Use of non-AliveCor approved accessories or
transducers and cables could result in electromagnetic emissions or decreased
electromagnetic immunity of this device and result in improper operation.
23. DO NOT use adjacent to or stacked with other equipment because it could result in
improper operation.
24. DO NOT use portable RF communications equipment (including peripherals such as
antenna cables and external antennas) closer than 30 cm (12 inches) to any part of the
KardiaMobile 6L System hardware. Otherwise, degradation of the performance of the
KardiaMobile 6L System could result.
Cautions
1. KardiaMobile 6L System does not detect heart attack.
2. DO NOT change your medication without talking to your doctor.
Instructions for Use for KardiaMobile 6L System
Page 6 of 24
3. Detection of arrhythmias in your EKG results is not to be used for diagnosis. If you are
experiencing any concerning symptoms, contact your physician.
4. Please consult with your physician should you receive consistent identifications of any
arrhythmia.
5. “Unreadable” EKG results determine that you didn't have proper EKG recording for analysis.
You may try to re-record your EKG.
6. The app may incorrectly identify Ventricular Flutter, Ventricular Bigeminy, and Ventricular
Trigeminy heart conditions as “Unreadable”. Please consult with your physician.
7. EKG reports viewed at any magnification other than 100% may appear distorted and could
lead to misdiagnosis. - Instructions for Use
- Visit the developer site
- Copyright
- © Copyright 2021 AliveCor, Inc. All Rights Reserved. US Patent No: 8,301,232 and Patents Pending. AliveCor is a registered trademark of AliveCor, Inc. in the United States and other countries.