Duns Number:079693152
Device Description: The ECG Check is intended for self-testing by patients at home. This 1-leadcardiac monitor The ECG Check is intended for self-testing by patients at home. This 1-leadcardiac monitor allows remote patients to display and transmit their EGG data tomedical professionals via a communication device to a remote server.Specifically, the EGG Check is indicated for patients who are concerned abouttheir heart rhythm and have experienced the following symptoms that aresuggestive of abnormal heart rhythms:* Skipped Beats* Pounding Heart (Palpitations)* Heart Racing or Irregular Pulse* Lightheadedness or Faintness* History of ArrhythmiasPrescription
Catalog Number
ECG01-Universal
Brand Name
ECG Check
Version/Model Number
ECG01-U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122184
Product Code
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
Public Device Record Key
10d65149-371d-4294-b0fc-bba278c7de92
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 28, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |