The Improvement of Movement
FLX Health Legal Status
FLX Health is regulated as a Medical Device in the United Kingdom and European Union. In the United States FLX Health is 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.
A Risk Assessment of FLX Health is a legal requirement and part of our obligations as a Medical Device, our assessment can reviewed here (PDF document):
Declarations of Conformity
The declarations of conformity and authorised representative details are given by region:
UKCA declaration of conformity. Authorised Representative address FLX Health Limited, C4DI @thedock, 31-38 Queen Street, Hull, HU1 1UU, UK.
CE declaration of conformity. Authorised Representative address Arco Safety Limited, Ballymount Corporate Park, Ballymount Ave, Ballymount, Dublin, D12 HY11, Ireland.
FLX Health falls into a category of Software as a Medical Device that is low risk (Physical Therapy) and is not required under FDA guideline 1741 to follow the requirements of the FD&C Act.