Rockfield Medical Devices, a commercial-stage medical device company focused on developing solutions for tube feeders, today announced U.S. Food and Drug Administration ("FDA") 510(k) Over the Counter Clearance (OTC) of the Mobility+ Enteral Feeding System.
This FDA clearance allows Rockfield Medical Devices to market the Mobility+ Enteral Feeding System for OTC use in the United States. The company continues to deliver on its mission to transform tube feeders' mobility and quality of life.
"We are excited to get OTC clearance which will allow the Company to supply the Mobility+ Enteral Feeding System without a prescription directly to the consumer (D2C) via multiple sales channels. This importantly will allow the company to supply Mobility+ to a greater number of tube feeders in a more efficient manner in the United States. This OTC clearance combined also with the new CMS reimbursement Code of B4148 for elastomeric feeding pumps will uniquely give users greater and faster access to the Mobility+ positively transforming mobility and Quality of Life of enteral tube feeders. This is a key to what we are about as a company, and hence our excitement to announce this positive news" said Tomás Thompson CEO of Rockfield Medical Devices.
The Mobility+ Enteral Feeding System is a portable, lightweight, elastomeric, enteral feeding system that delivers liquid nutrition formula to an enteral access device (feeding tube) in users aged two years and over, in clinical or home care settings. The system has three primary components: a food pouch, a filling set and a giving set. The Mobility+ is for single patient use and is intended for use over a 24-hour period.
Market release of Mobility+ OTC is anticipated in Q3 2024 in the United States.
