BITalino

It is not a medical device nor is it intended for medical diagnosis and provided to you "as is," and we make no express or implied warranties whatsoever with respect to its functionality, operability, or use, including, without limitation, any implied warranties, fitness for a particular purpose, or infringement. We expressly disclaim any liability whatsoever for any direct, indirect, consequential, incidental or special damages, including, without limitation, lost revenues, lost profits, losses resulting from business interruption or loss of data, regardless of the form of action or legal theory under which the liability may be asserted, even if advised of the possibility of such damages.

 


biosignalsplux

Products are intended for use in life science education and research applications; they are not medical devices nor are they intended for medical diagnosis, cure, mitigation, treatment or prevention of disease. we expressly disclaim any liability whatsoever for any direct, indirect, consequential, incidental or special damages, including, without limitation, lost revenues, lost profits, losses resulting from business interruption or loss of data, regardless of the form of action or legal theory under which the liability may be asserted, even if advised of the possibility of such damages.

CE Mark & Decleration of Conformity

biosignalsplux is certified as electronic device with intended use for life science research and educational purposes. It is in compliance with the essential requirements of the following directives, if applied in accordance with the manufacturer's specifications and instructions:

  • Radio Equipment Directive 2014/53/EU Article 3.1(a) Safety and Health Standards
  • Radio Equipment Directive 2014/53/EU Article 3.1(b) Electromagnetic Compatibility
  • Radio Equipment Directive 2014/53/EU Article 3.2. Efficient Use of Spectrum Standards
  • RoHS Directive 2011/65/EU
  • Human Exposure EMF EN 62311 (2008)
  • EMC EN 60601-1-2 (2015)

 


physioplux

Electromyographic Biofeedback product line designed specifically for exercise training in physiotherapy & sports: physioPlux Clinical, a medical device designed for clinical usage, which includes a full range of applications for different conditions; physioPlux Trainer, a product designed for home training, with a simple, intuitive and totally pre-seted application, that receives the specific customized prescription from the physioPlux Clinical; physioPlux Go, a simple device designed for free use home training. ISO-13485 compliance | Complies with Requirements put forth by the medical sensor Directive 93/42/EEC. Class I device, Annex VII. FDA and CE approved.