De Novo DEN130047

Device: PROLONG
Contact: barry pearce
De Novo number: DEN130047
Product code: PIA
Regulation: 876.5025
Classification name: vibrator for climax control of premature ejaculation
Decision: granted (DENG)
Decision date: 2015-03-20
Date received: 2013-11-18
Classification advisory: Gastroenterology/Urology
Review advisory: Gastroenterology/Urology
Type: Direct

Current FDA Classification#

Product code: PIA
Device name: Vibrator For Climax Control Of Premature Ejaculation
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation: 876.5025
Implant: N
Life sustain/support: N