Skip to contentDe Novo DEN220059
- Device
- NTX100 Tonic Motor Activation (NTX100 ToMAc) System
- Contact
- shriram raghunathan
- De Novo number
- DEN220059
- Product code
- QWD
- Regulation
- 882.5887
- Classification name
- stimulator, nerve, for restless legs syndrome
- Decision
- granted (DENG)
- Decision date
- 2023-04-17
- Date received
- 2022-09-21
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- QWD
- Device name
- Stimulator, Nerve, For Restless Legs Syndrome
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.5887
- Implant
- N
- Life sustain/support
- N