FDA.reportPublic FDA data

De Novo DEN100024

Device
ZAP-IT!
Contact
kevin walls
De Novo number
DEN100024
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
2010-09-09
Classification advisory
Neurology
Review advisory
Neurology
Type
Post-NSE

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