Wearlinq
EKG & Virtual Cardiology
Only for iPhone
Free
iPhone
Welcome to Wearlinq and AMI Cardiac Monitoring!
After your doctor prescribes the device, record your EKG data 24/7 with the FDA-cleared eWave monitor.
MEET THE EWAVE
- 24/7 continuous multi-channel EKG recording wherever you are
- Direct transmission and display in the Wearlinq app
- Keep the eWave after your prescription period to capture further symptoms
HOW DOES IT WORK?
1. Download the Wearlinq app
2. Wear the eWave during your prescription time
3. We will send your results to your cardiologist when complete.
NOTE: Requires the eWave device to record your EKG. Neither the app nor the eWave automatically call emergency services or provide treatment.
FDA 510(k) number: K214073 - only cleared for US use.
Ratings & Reviews
We are always working hard to make the Wearlinq experience even better.
The developer, Wearlinq, 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 Linked to You
The following data may be collected and linked to your identity:
- Health & Fitness
- Contact Info
- Identifiers
Data Not Linked to You
The following data may be collected but it is not linked to your identity:
- Diagnostics
Accessibility
The developer has not yet indicated which accessibility features this app supports. Learn More
Information
- Seller
- Wearlinq, Inc.
- Size
- 47.3 MB
- Category
- Medical
- Compatibility
Requires iOS 17.0 or later.
- iPhone
Requires iOS 17.0 or later.
- iPhone
- Languages
- English and Spanish
- Age Rating
13+
- 13+
- Infrequent
Medical Treatment information
- Medical Device
Yes
- Wearlinq, 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
- 10087780
- Address
- 1819 Polk St
Ste 148
San Francisco California 94109-3003
United States - Phone Number
- +1 415-234-0506
- info@wearlinq.com
- Use Statement
- The eWave monitor is an ambulatory ECG monitor intended to provide continuous extended duration cardiac monitoring. It is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, pre-syncope, syncope, fatigue, or anxiety.
- Safety Information
- Warnings:
Patients with potentially life-threatening arrhythmias who require inpatient Monitoring. Portable and mobile wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, computers with wireless internet, and Bluetooth connected devices can affect the eWave and should be kept at least a distance of 30 centimeters (12 inches) away from the equipment. Position the eWave away from other electrical or electronic equipment, if possible. The presence of strong EMI fields, or electronic, surgical, or diathermy instruments in close proximity to the ECG device may cause trace noise or input overload conditions. The ECG device is compliant with IEC 60601-1-2 EMC immunity requirements. Do not use the eWave patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patients may experience skin irritation.Do not reuse the eWave on multiple patients during a single prescription period.
Reuse will cause incorrect patient data and patients may experience cross contamination.DO NOT use the eWave to self-diagnose heart related conditions. Consult with your physician before making any medical decision, including altering your use of any drug or treatment.. The device has not been tested for and is not intended for pediatric use.Keep the device away from young children. Contents may be harmful if swallowed. The transmitter contains batteries that are not accessible during normal use but, if exposed, are known choking hazards and may cause severe tissue injury if ingested.
DO temporarily remove the device while exposed to a magnetic resonance (MR) environment.. DO NOT use the device with a cardiac pacemaker, ICDs, or other implanted electronic devices. DO NOT use the device adjacent to or stacked with other equipment because it could result in improper operation.
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 eWave. Otherwise, degradation of the performance of the eWave could result. DO NOT use it on infants weighing less than 10 kg.
Temporarily take off and store the eWave transmitter in the charging case while in aircraft environments. May interfere with defibrillation therapy. To avoid ineffective defibrillation therapy, remove the eWave and patch before applying any external cardiac defibrillators. This device is solely intended for manual interpretation of the recorded ECG.
Precautions:
Do not keep the eWave transmitter or your cell phone within 10 cm of a Wi-Fi router.Apply the adhesive patches only to intact, clean skin. Do not apply over open wounds, lesions, infected or inflamed areas. Do not use lotions, oils or sprays on the skin location where you will apply the adhesive patch.
Do not use the eWave if the casing is broken or damaged. Do not disassemble the eWave.United States federal law restricts the device to sale by or on the order of a licensed practitioner or therapist. Safety and effectiveness of the eWave on patients receiving any form of pacing therapy has not been established. Paced cardiac rhythms may not be accurately detected and may be incorrectly classified. Safety and effectiveness of the eWave on pediatric patients (younger than 18 years old) has not been established.The eWave system includes temperature and humidity limitations when stored/transported. If exposed during storage/transport, patients may experience degradation of adhesive performance causing the patch to slip or fall off during the patient wear duration. In that case, just apply a new patch. The adhesive patches and transmitter have a shelf-life date. Use of expired devices may cause a degradation of ECG signal quality and/or low battery condition. The lot number and expiry date for the patches can be found on the pouch they arrive in.
- Instructions for Use
- Visit the developer site
- Copyright
- © Wearlinq, Inc.