FDA.reportPublic FDA data

De Novo DEN170028

Device
Cala ONE
Contact
scott a. wilson
De Novo number
DEN170028
Product code
QBC
Regulation
882.5897
Classification name
external upper limb tremor stimulator
Decision
granted (DENG)
Decision date
2018-04-26
Date received
2017-05-17
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
QBC
Device name
External Upper Limb Tremor Stimulator
Medical specialty
Neurology
Device class
2
Regulation
882.5897
Implant
N
Life sustain/support
N