Not only is Erchonia as a company certified, as detailed on the Certification of Company page, but more importantly, our devices are certified. As a quality certified company, our devices are manufactured in accordance to strict, well-documented quality control measures, with each device undergoing performance tests during production and verification testing prior to passing our Quality Control Inspector. This in itself would be sufficient for some companies to claim “certification,” but not Erchonia. Even before one of our devices is released to Production, during the Research and Development phase we are proving the device safety through pre-compliance examination to ensure all of the components used in conjunction pass the standards.  We then take testing to another level when a sample of each device undergoes ISO 60601 for Medical Device EMC and Safety standards. These tests are conducted by a third party independent laboratory, who is well respected world wide as a Medical device compliance laboratory. These independent test results are used to obtain FDA clearance, CE Mark and international licenses.

Links

Device Listings
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm
type ERCHONIA in the Establishment field