The FDA said it down-classified the Prolong device, a vibrator used to treat premature ejaculation, from Class III to Class II after a request from Ergon Medical Ltd., creator of the device.
That means Prolong has the same classification as general-use devices such as condoms, according to the FDA. The reclassification was posted March 20 and goes into effect today, the safety watchdog said.
The Prolong device won de novo clearance from the FDA in March, according to FDA’s website.
Prolong is designed to use repeated subthreshold stimulation of the penis to produce a long-term reduction of sensitivity, through an effect called habituation which is thought to be permanent, West Sussex, U.K.-based Ergon Medical said in a press release.
Prolong won CE Mark approval in the European Union in 2012, after data was presented at the World Meeting of Sexual Medicine. Dr. Andy Zamar of the London Psychiatry Centre invented the device and is listed as chairman of Ergon Medical.