Skip to contentDe Novo DEN200050
- Device
- Portable Neuromodulation Stimulator (PoNS)
- Contact
- lawrence picciano
- De Novo number
- DEN200050
- Product code
- QCF
- Regulation
- 882.5889
- Classification name
- electrical tongue stimulator to treat motor deficits
- Decision
- granted (DENG)
- Decision date
- 2021-03-26
- Date received
- 2020-08-04
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QCF
- Device name
- Electrical Tongue Stimulator To Treat Motor Deficits
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5889
- Implant
- N
- Life sustain/support
- N