FDA.reportPublic FDA data

De Novo DEN210055

Device
The N-SWEAT Patch
Contact
scott a. wilson
De Novo number
DEN210055
Product code
QVX
Regulation
878.4425
Classification name
skin patch for treatment of hyperhidrosis
Decision
granted (DENG)
Decision date
2023-04-07
Date received
2021-12-03
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Direct

Current FDA Classification#

Product code
QVX
Device name
Skin Patch For Treatment Of Hyperhidrosis
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4425
Implant
N
Life sustain/support
N