De Novo DEN130019

Device
ZANZA-CLICK
Contact
claude berthoin
De Novo number
DEN130019
Product code
OSG
Regulation
882.5894
Classification name
piezo-electric stimulator for relief of mosquito bite itch
Decision
granted (DENG)
Decision date
2014-11-07
Date received
2013-02-28
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
OSG
Device name
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Medical specialty
Neurology
Device class
2
Regulation
882.5894
Implant
N
Life sustain/support
N