MARCH 9, 2011 - DynaFlex, a manufacturer specializing in orthodontic appliances, has obtained FDA 510(k) clearance (K103076) from the US Food and Drug Administration for its DynaFlex® Anti-Snoring & Sleep Apnea Devices line of sleep aid products. Designed to treat snoring and sleep apnea, the DynaFlex products function by repositioning patients’ lower jaws to improve breathing ability during sleep. The devices are available in four model types, and are custom-fitted for each patient based on jaw measurements taken by prescribing health care providers.The company undertook its FDA 510(k) clearance process in early 2010 with the assistance of Emergo Group, a medical device regulatory and quality assurance consultancy. Emergo Group provided an initial analysis of DynaFlex® Anti-Snoring & Sleep Apnea Devices to determine the most cost-effective and accurate method for submitting DynaFlex’s 510(k) documents, followed by preparation and submission of the 510(k) application to the FDA for review and clearance. Emergo Group also assisted DynaFlex in assuring compliance with the FDA Quality System Regulation, 21 CFR Part 820... DynaFlex's Press Release -
