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UKCA Mark
eWellness Ltd
![](https://feed.iplaysafe.app/wp-content/uploads/2021/08/1-REF.png)
Catalogue number
eWellness Platform
![](https://feed.iplaysafe.app/wp-content/uploads/2021/08/2-LOT.png)
Version
Release R1 [Version 1.0.17(57)]
![](https://feed.iplaysafe.app/wp-content/uploads/2021/08/3-Info.png)
Instructions before use
Refer to instructions for use for instructions before use
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Manufacture
eWellness Ltd at PO 976, Richmond Upon Thames, TW9 9JH
This device fulfils the provisions of the European Commission (EC) Directive 93/42/EEC ( Medical Devices Directive).
This software product has been design according to:
ISO 13485:2016
Medical devices - Quality management system - Requirements for regulatory purposes
DBC0129
Clinical Risk Management: its Application in the Manufacture of Health IT Systems
DBC0160
Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
ICE 62304:2006 Amd 1:2015
Medical device software - Software lifecycle processes.
This device has been developed under the strict quality system of eWellness Ltd.