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eXroid and Ultroid

eXroid provided electrotherapy treatments in the UK from 2013 to 2016 using equipment purchased from a US supplier, Ultroid Marketing Development Corporation (together with its affiliates called “Ultroid”). In April 2015, the US Food and Drug Administration (FDA) sent inspectors to Ultroid’s offices who raised questions about their compliance with US regulations. The FDA sent a warning letter to Ultroid later in 2015 (see https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463616.htm ). This led to the recall of Ultroid equipment and treatment kits (including those being used by eXroid) in September 2016.

The reason Ultroid gave for this recall was that the equipment and treatment kits “may not have been designed, qualified, manufactured, and/or managed under a state of control per internal quality assurance procedures and US regulations . . .” Ultroid also stated that “there have been no reports of adverse reactions associated with the use of [Ultroid equipment] in the United States . . .” The recall meant that we had to immediately cease providing electrotherapy treatments in the UK, which was very disappointing to patients awaiting treatment and to our directors.

Because of this situation, we changed the name of the company to eXroid Technology Ltd (it was originally called “Ultroid UK Ltd”) and decided to design and manufacture electrotherapy equipment in the UK in compliance with European regulations and standards. The new equipment is capable of safely providing the same electrotherapy treatments for haemorrhoids as were previously provided using Ultroid equipment. eXroid currently has no relationship with Ultroid.

 

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