DynaFlex Wins FDA 510(k) Clearance for Sleep Aid Devices
Manufacturer's line of products to treat snoring and sleep apnea cleared with assistance from Emergo Group.
March 9, 2011 - PRLog -- St. Ann, MO —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.
“Emergo Group outlined the 510(k) submission process very thoroughly to help me understand my responsibilities,”
“Firms like DynaFlex have invested major time and money toward designing innovative medical devices,” says Rene van de Zande, President and CEO of Emergo Group. “Ensuring a smooth and successful approval process, whether you’re dealing with the FDA or any other market regulator, necessitates a partner with the know-how and proven track record to improve your chances of bringing your product to market.”
DynaFlex is a leading manufacturer and provider of orthodontic appliances and lab services. Since 1965, the company has provided high quality products and services to specialists and doctors worldwide.
About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for device registration, QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting.
For additional information, please contact:
Darren Buddemeyer, President