Chambersburg, Pennsylvania-based medical device technology developer Reflexonic has received FDA approval for its Viberect device aimed at men with mild to moderate erectile dysfunction (ED) symptoms, including those undergoing post-prostatectomy erectile rehabilitation and those with spinal cord injuries causing ejaculatory dysfunction. Instead of relying on a little blue pill to get things ready for the bedroom, the device, which looks a bit like a hair crimper, delivers targeted nerve stimulation to both dorsal and ventral surfaces of the penis using medical Softpads.
Developed around the belief among scientists that penile erection is the combination of multiple successful nerve reflexes that initiate a vascular event, the Viberect mimics rapid and repetitive manual/vaginal stimulation of the penis through simultaneous stimulation of both surfaces of the penis at high frequency - 70 to 110 Hz. Using the device for about seven to ten minutes stimulates the millions of nerves receptors that line the surface of the penis, which communicate with sexual centers in the brain and the spinal cord that initiate gradual filling of the penis with arterial blood to prepare the user of sexual intercourse.
In addition to helping strengthen and maintaining the rigidity of an erection, Reflexonic also says, "subsequent orgasm and ejaculation is greatly amplified."
Quoting a recent epidemiological study of the use of vibrators by American women and men, Reflexonic says vibratory stimulation, like that delivered by the Viberect, is considered safe by the medical community. The company says the device has been demonstrated to be a safe and effective device for provoking erections for men who suffer from mild to moderate ED and men who have suffered spinal cord injuries.
Reflexonic obtained final FDA approval for Viberect to be sold with a doctor's prescription in June and plans to begin sales of the device this northern summer at a price yet to be announced. Sales will be through the Reflexonic website and it will ship orders worldwide.
Via MedGadget
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Snake oil salesman often use FDA submission or clearance to legitimize their claims.