Regulatory Compliance and PDG Product Testing

PDG Mobility (Product Design Group Inc.) is a Class I Manufacturer of Medical Devices.

 

United States

Food and Drug Administration - Registration Number 9681827

Click here to view the Registration

 

Canada

Health Canada - Medical Device Establishment Licence Number 3228

Click here to view the License

 

European Union

European Communities Council - CE Certificate No. CAN/2001/05/03

Click here to view the Certificate of Registration and the Declaration of Conformity

 

 

The following links allow you to obtain copies of test reports and declarations provided by independent test laboratories

 

ISO Wheelchair Standards Testing

PDG wheelchairs are tested to ISO standards at Novitatech Testing Laboratory in Australia. Novitatech was created to assist the International Standards Organisation (ISO)  to produce a range of quality and performance Standards for wheelchairs and other rehabilitation equipment. Novitatech is an internationally registered test facility that conducts wheelchair testing.

The Test reports provided by Novitatech are based on ISO wheelchair standards. The test reports provide information the reader can use to compare against ISO requirements.


ISO Test Lab Cover letter - Elevation
ISO Test Lab Cover letter - Bentley
ISO Test Lab Cover letter - Eclipse

ISO Test Lab Cover letter - Fuze T50

ISO Test Lab Cover letter - Fuze T20

ISO Test Lab Cover letter - Stellar

ISO Test Lab Cover letter - Stellar HD

ISO Test Lab Cover letter - Stellar GL

ISO Test Lab Cover Letter – Stellar LEAP
ISO Fire Resistance Test Report - Upholstery

ISO Test Report - Elevation

ISO Test Report - Bentley

ISO Test Report - Eclipse

ISO Test Report - Fuze T50

ISO Test Report - Fuze T20

ISO Test Report - Stellar

ISO Test Report - Stellar HD

ISO Test Report - Stellar GL

ISO Test Report – Stellar LEAP