Important Information
physioplux has been discontinued on the 31st of December 2022.
Find all relevant information about the discontinuation process in the following article:
physioplux Product Line Discontinuation
physioplux is an 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 / CE Mark / CE certified.
Safety & Standards
The medical devices described hereafter:
- physioplux Clinical shoulder
- physioplux Clinical knee
- physioplux Clinical pelvic
- physioplux Clinical pro
- physioplux Clinical expert
have been classified a Class I and are in conformity with the essential requirements and provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and are in conformity with the European standards transposing harmonised standards:
- Radio Equipment Directive 2014/53/EU
- Electromagnetic Compatibility Directive (EMC) 2014/30/EU
- Restriction of Hazardous Substances (ROHS) Directive 2011/65/EU
- Human Exposure EMF EN 62311 (2008)
- EMC EN 60601-1-2 (2015)
- Safety tests EN 60601-1-2006+A11-2011+A1-2013+ A12-2014
The medical devices are subjected to registration to the National Authority for Medicament and Health Products, INFARMED, Parque de Saúde de Lisboa, Avenida do Brasil 53, 1749-004 Lisbon, Portugal.
You can find the Declarations of Conformity for physioplux devices below for regulatory purposes.
Declaration of Conformity: physioplux
The Declaration of Conformity (CE Mark / CE Certification) is provided for the entirety of the physioplux systems described in the Declaration of Conformity:
