Company's Viberect hand-held, non-pharmaceutical device to treat ED obtains FDA 510(k) clearance with support from Emergo Group
Online PR News – 21-July-2011 – – Reflexonic, LLC, a Chambersburg, Penn.- based medical device technology developer specializing in urology, has achieved 510(k) clearance from the US Food and Drug Administration to market its non-pharmaceutical product to treat erectile dysfunction (ED), Viberect™.
The Viberect device targets men with mild to moderate ED symptoms, poor maintenance and rigidity, and men undergoing post-prostatectomy erectile rehabilitation as well as those with spinal cord injuries causing ejaculatory dysfunction. Viberect functions via scientific frequency/amplitude vibratory stimulation of penile nerves in order to activate sexual pathways leading to successful erection, penile rigidity, and ejaculation. The device is used easily at home prior to sexual activity.
Reflexonic partnered with Emergo Group, an Austin, Texas-based medical device regulatory consultancy, in its US regulatory clearance effort. After consulting with the FDA and determining that pursuing premarket notification would be the appropriate path to market, Reflexonic and Emergo Group spent two months writing a 510(k) application, which was submitted in February 2011. Reflexonic obtained final 510(k) clearance in late June.
“Emergo Group provided the support and expertise we required to successfully identify predicate devices for Viberect and prepare a successful submission to the FDA,” says Dr. Kambiz Tajkarimi, Founder and President of Reflexonic. “Reflexonic is now set to begin marketing the first hand-held, non-pharmaceutical device to provoke natural penile erection and ejaculation in the US.”
Jean Asquith, Senior Consultant at Emergo Group, adds, “The 510(k) process is typically not easy. After expending significant time, money and energy developing a truly innovative medical device, Reflexonic chose to partner with us in order to ensure their FDA review went as smoothly and efficiently as possible so that they could sooner focus on sales and distribution efforts.”
About Reflexonic, LLC
Reflexonic is a urologist-owned and operated US medical device company dedicated to creating simple, intelligent, and physiological hand-held devices that millions of men and women can use to restore and preserve their sexual and urinary health. Further information can be found at http://www.reflexonic.com
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:
Dr. Kambiz Tajkarimi, Founder and President