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.
Certificate of Conformity
EU Declaration of Conformity