The U.S. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that apply to food, drugs, cosmetics, biologics, radiation-emitting electronic products, and medical devices.
The APT is registered with the FDA as a Physical Medical Device under product code BXB – Powered Exercise Equipment Class I
EC certificate is specifically for the APT confirms that:
Product Category: Active rehabilitation devices Exerciser/Training aid for disabled person Class lla The Certification Body of TUV SUD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex V. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance.
EN ISO 13485:2016 is a certificate that confirms that the company complies to the requirements for Medical Devices Quality Management Systems the scope of the certificate is:Production, Sales, Distribution and Servicing for Powered Mobility Trainers.
The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system which meets the requirements of the listed standard(s)