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Certification

Medical classification of Vertebral Mobilisers

 

          Vertebral Mobilisers have been classified by the MHRA, (The Medicines and Healthcare products Regulatory Agency), as Class IIa medical devices.

 

All Class IIa medical devices must comply with a strict certification process according to Medical Directive 93/42/EEC.

 

This requires products to be tested to EN 60601 with a test protocol and quality system set up and audited by a notified body.

 

Theraflex Ltd manufactures the EPVM 1 according to this procedure with all units being individually tested by our appointed notified body; BSI Product Services.

 

 

BSI

Certificate of Conformity

       Theraflex Ltd                

EU Declaration of Conformity