FLX Health Legal Status

FLX is general health product that improves the way people move to benefit general musculoskeletal and biomechanical health.  FLX is primarily aimed at healthy users who wish to improve the way they move to reduce the risk of future musculoskeletal problems or injury.  The pain programmes used in FLX are generic and not personalised to the individual person, as such they fall outside of the definition of software as a medical device (MDCG 2019-11, Rule 4) for the UK and Europe.  In the United States FLX Health may be classified as Software as a Medical Device, but falls into a low risk category that is not required to comply with the requirements of the Federal Food, Drug and Cosmetic Act (FDA Guideline 1741 relating to Physical Therapy).

 

We have conducted a Risk Assessment of FLX as part of our obligations as a responsible service provider, our assessment can be reviewed here (PDF document):