De Novo DEN100023

Device
AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
Contact
david wise
De Novo number
DEN100023
Product code
OSD
Regulation
890.5670
Classification name
massager, therapeutic, to internally massage trigger points in the pelvic floor musculature
Decision
granted (DENG)
Decision date
2012-11-20
Date received
2010-08-20
Classification advisory
Physical Medicine
Review advisory
Physical Medicine
Type
Post-NSE

Current FDA Classification#

Product code
OSD
Device name
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Medical specialty
Physical Medicine
Device class
2
Regulation
890.5670
Implant
N
Life sustain/support
N