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.
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.