Skip to contentDe Novo DEN110009
- Device
- RESTLESS LEG DEVICE
- Contact
- mary m sorg
- De Novo number
- DEN110009
- Product code
- OTX
- Regulation
- 890.5760
- Classification name
- foot wrap for treating restless leg syndrome symptoms
- Decision
- granted (DENG)
- Decision date
- 2013-12-18
- Date received
- 2011-01-27
- Classification advisory
- Physical Medicine
- Review advisory
- Neurology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OTX
- Device name
- Foot Wrap For Treating Restless Leg Syndrome Symptoms
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation
- 890.5760
- Implant
- N
- Life sustain/support
- N