At Adjustamatic we are proud to say that all of our products which Include our unique NHC Cyclo-Therapy massage system are classified as Class 2a medical devices and as such carry the European Union CE mark. This means that our products are manufactured to strict European regulations which ensure the products are of the highest standard. When looking to purchase an Adjustable Bed or Riser Recliner Chair you can be reassured that at Adjustamatic we want to make sure you are delivered the very best in quality and urge you to check the validity of standards when comparing market competition.
A Class 2a medical device is a product that is used to prevent and treat a wide range of conditions including arthritis and the myriad of those affected by poor circulation. A Class 2a medical device does not achieve its result through chemical action with or on the body. Medical devices act through alternative means being physical and mechanical. The design of a medical device constitutes a major segment of biomedical engineering and so requires regulation and recognition when meeting EEC Directives.
At Adjustamatic we manufacture all of our products within our own factory in North Wales and have done so for over 50 years. We are dedicated to producing only the very best in quality and as a result are ISO (International Organisation for Standardisation) 13485:2003 and EN ISO 13485:2012 certified since 1999. The later ISO standard 13485 was introduced in 2003 and is a requirement for conformity to the EEC directive 93/42/EEC for medical devices which under guidelines must be addressed before a medical device can be sold
All Adjustamatic medical devices that carry Class 2a medical device certification, and have done since 2004, are audited over the period of one week on an annual basis to ensure every aspect of the directive is met. The result of positive assessment each year is the certificate of conformity allowing use of the CE mark and permission to sell medical devices throughout the European Union. This certification is regulated by the MHRA (Medicines and Healthcare Regulatory Authority)
The MHRA are a government run operation whose mission is to enhance and safeguard the health of the public by ensuring that medical devices work and are safe. Adjustamatic are proud to continue to meet strict regulations ensuring that our customers not only get the very best in design and comfort but that this is supported with our stringent quality measures and Class 2a medical device certification