Hologenix: IR technology registered as a clas...

IR technology registered as a class 1 medical device

(Source: Hologenix)
(Source: Hologenix)

The awareness of the benefits of infrared (IR) textiles, which absorb body heat and reflect it back as therapeutic infrared energy, has grown over the last 10 years. In 2017, the Food & Drug Administration (FDA), Silver Spring, MD/USA, determined that products containing Celliant from Hologanix are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and are general wellness products because they are intended to temporarily increase blood flow and local circulation at the site of the application in healthy individuals.
»We firmly believe that regulatory status matters and that is why we have grown the number of countries we have such relationships with by over a third in the last 3 years.«
Seth Casden, Co-Founder and CEO, Hologenix

Celliant is designated as a Class 1 Medical Device in 38 countries and cleared to market in 15 (China, India, Indonesia, Korea, Malaysia, Mexico, Peru, Philippines, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam) with more countries and regions to follow. This elevated status in 53 countries translates to Celliant being a good partner for global companies who are seeking innovation in textiles to distinguish their products.
Celliant is a proprietary blend of natural minerals from Hologenix, LLC, Pacific Palisades, CA/USA, that allows textiles to convert body heat into infrared energy, returning it to the body and temporarily increasing local blood flow and cellular oxygenation.
Celliant is designated as a Class 1 Medical Device in Australia, Canada, the EU and European Economic Area (EEA), Japan, New Zealand, the UAE, the UK and the USA.

Hologenix, Celliant = registered trademarks

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