IMPORTANT: MEDICAL DEVICES - LEGAL REQUIREMENTS



1. DEVICE VALIDATION AND SAFETY


All medical devices sold in the UK are now legally required to meet the UK MHRA (MEDICINES AND HEALTH PRODUCTS REGULATORY AUTHORITY) REGULATIONS. 


All of our  ‘SPECIFIC-CONDITION’, and our PHYSIO focused PEMF devices are fully MHRA/EU registered as CLASS 2 MEDICAL DEVICES.   


YOU CAN SEE OUR DEVICE REGISTRATIONS HERE… (MANUFACTURER NAME: I.A.C.E.R).

 

WE STRONGLY ADVISE ANYONE WHO IS LOOKING FOR A PEMF DEVICE TO CHECK THEY ARE LOOKING AT LEGALLY REGISTERED MEDICAL DEVICES ONLY.

 

 




2. UNREGULATED DEVICES: CAUTION!


There are a growing number of unvalidated and unregistered PEMF mats/devices which are presented to customers as ‘Wellness Devices’

 

These devices typically fall into 1 of 2 categories:

 

Low Powered Wellness Devices

These deliver very low-power/low-intensity, multiple-frequency treatment sessions. 

Typically they provide only 1-25 Gauss of field-intensity (often not disclosing this information to customers). Most often they are not presented as targeting specific tissues but are providing general ‘bathing’ of the bodies cells in a range of fields to aid healing.


These are aimed at maintaining general wellness (aiding detox, helping circulation etc)

It is difficult to validate their effectiveness claims - simply because they do not submit their products for independent validation and testing under the MHRA Medical Device Regulations!

 

Ultra-High Powered Wellness Devices

We are also aware that some manufacturers selling into the UK home user market are using extremely high powered “wellness” devices. Again these to our knowledge have not been submitted for validation for quality/safety/effectiveness under the UK/EU Medical Device Regulations.


SOME OF THESE DEVICES ARE SERIOUSLY POWERFUL TOO! AS POWERFUL AS HOSPITAL MRI SCANNERS! (20-30 THOUSAND GAUSS). WHILST HOSPITAL MACHINES ARE TESTED TO MEET STRICT  SAFETY STANDARDS - MANY OF THESE DEVICES ARE NOT.


WE URGE CAUTION FOR ANY HOME-USE DEVICE  WHICH IS QUOTED AS RUNNING INTO THE THOUSANDS OF GAUSS.