Certifications for Viberect ®:
FDA (USA)
CE (European Union)
ISO 13485:2003
CMDCAS, Health Canada,
TGA (Australia),
EN 60601-3, India
Notes:
FDA Indications:
Class II medical device for home and clinic use to provoke penile erection in men with erectile dysfunction, and to provoke ejaculation in men with spinal cord injury.
CE Indications:
Penile vibratory stimulation device for the treatment of erectile and ejaculatory disorders.
