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FDA Medical Device Registration

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

CE Medical Device Certification

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.

ISO 13485 Certification

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)

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