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Reflexonic Viberect wins FDA nod

Reflexonic, a developer of hand-held devices, has received the US Food and Drug Administration 510(k) clearance for its Viberect to treat erectile dysfunction (ED).

Viberect functions via a scientific frequency/amplitude vibratory stimulation of penile nerves to activate sexual pathways leading to successful erection, penile rigidity and ejaculation.

Reflexonic founder and president Kambiz Tajkarimi said a medical device consulting firm- Emergo provided the support and expertise they required to identify predicate devices for Viberect and prepare a successful submission to the FDA.