FDA Registration Number: 3006746294
Device FDA Listing: D145295
Device Classification Name: lamp, infrared, therapeutic heating
510 (K) Number: K081505 Regulation number: 21 CFR 890.5500
Conforms with Council Directives 2004/108/EC and 2006/95/EC by the application of BS EN 60601-1-2, EN 61000-6-2 and EN60950-1
Theragem has been officially safety tested in compliance with the European Union legal directive by licensed and certified independent testing companies in the United Kingdom.
Theragem is built using the finest components to conform to EU electrical compliance. Our aim is to deliver reliability, mechanical strength, stability and safety as standard.
The full test reports from Intertek and Metecc are available for inspection at our offices.