Discover the cabin Body Boost Bed
Bioledtherapy , a specialist in photobiomodulation (PBM) based in Lille, France, Bioledtherapy innovative solutions to improve health and well-being using red and near-infrared light.
We are proud to be the exclusive distributor in France of the Body Boost Bed full-body red light therapy bed, a medical device featuring state-of-the-art PBM technology.
The Body Boost Bed cabin Body Boost Bed available in Canada for personal use Body Boost Bed .
The documentation
Body Boost Bed Documentation
Regulations
Transparency and Regulatory Compliance
Body Boost Bed™ is a European Class IIa medical device manufactured to the highest standards and independently tested.
Body Boost Bed™ is also approved by the FDA (Food and Drug Administration)
Registration Number: 3020763249
Owner-Operator Number: 10082824
Certifications
EN 60601–1:2006 +A1:2013 +A12:2014 +AC:2014 Medical electrical equipment. General requirements for basic safety and essential performance
- EN 60601–1-2:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests.
- EN 60601–1-6:2010+A1:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
- EN 62366–1:2015+AC:2015 Medical devices. Application of usability engineering to medical devices.
- EN 62471:2008 Photobiological Safety of Lamps and Lamp Systems
- EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes.
- EN ISO 14971:2012 Medical devices. Application of risk management to medical devices.
- EN ISO 10993-1:2009+AC:2010 Biological evaluation of medical devices. Evaluation and testing within a risk management process
- EN ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
- EN ISO 10993-10:2009 Biological evaluation of medical devices. Tests for irritation and delayed-type hypersensitivity
- EN ISO 15223–1:2016 Medical devices — Symbols to be used with medical device labels, labeling, and information to be provided
Education
Studies on Photobiomodulation
Simulator