De Novo DEN110011

Device
SYMPHONY DEVICE
Contact
fred burbank
De Novo number
DEN110011
Product code
OVP
Regulation
882.5895
Classification name
vibratory counter-stimulation
Decision
granted (DENG)
Decision date
2013-12-18
Date received
2011-07-13
Classification advisory
Physical Medicine
Review advisory
Neurology
Type
Post-NSE

Current FDA Classification#

Product code
OVP
Device name
Vibratory Counter-Stimulation
Medical specialty
Physical Medicine
Device class
2
Regulation
882.5895
Implant
N
Life sustain/support
N