Standards

What this site and this device are built to, what has been measured. Last reviewed 2026-09-01.

This website

Accessibility

Built and tested to the Web Content Accessibility Guidelines 2.2, Level AA, which is also the basis for alignment with Section 508 and EN 301 549. Details and known gaps are in the accessibility statement.

Security

This website is a set of static pages. There is no database, no login, no server-side application and nowhere to enter personal information, which removes most of the risk a healthcare website ordinarily carries. All traffic is encrypted in transit over HTTPS, and the site is served with the current set of browser security protections enabled at the server.

Privacy

No cookies, no analytics, no tag manager, no tracking pixels, no advertising technology and no third-party scripts. Fonts are served from this site rather than from a font service, so reading a page here tells no one else that you were on it. This is how the site is built rather than a promise about how it is operated: there is nothing present that could collect the data. The privacy policy sets out the same boundary in full, including where it stops, which is the clinical service.

The GutTracker device

The G-Tech Wireless Patch System is cleared under 510(k) K212954, product code MYE, regulation 21 CFR 876.1735, Class II.¹ The standards below are those the system was tested against in that submission, as recorded in the 510(k) Summary.

Electrical safety and electromagnetic compatibility

• IEC 60601-1:2005, medical electrical equipment, general requirements for basic safety and essential performance
• IEC 60601-1-2:2014, electromagnetic disturbances
• IEC 60601-1-6:2010, usability
• IEC 60601-1-11:2015, medical electrical equipment used in the home healthcare environment
• ANSI C63.27-2017, evaluation of wireless coexistence

Biocompatibility

Assessed against ISO 10993-1:2009, biological evaluation of medical devices. The patch has been assessed as compliant for contact with intact skin for up to 30 days.

Software and cybersecurity

Software documentation was developed in consideration of the FDA guidance documents Content of Premarket Submissions for Software Contained in Medical Devices and Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices.

Quality system and regulatory obligations

As a device manufacturer G-Tech operates under the general controls of the Federal Food, Drug, and Cosmetic Act, including establishment registration and device listing (21 CFR Part 807), labeling (21 CFR Part 801), medical device reporting (21 CFR Part 803), and the Quality Management System Regulation (21 CFR Part 820, incorporating ISO 13485:2016). To report a device problem, see report a problem.

For more information, please contact us at info@gtechhealth.com.