De Novo DEN250067
- Device
- ReneuRx™ (Neural Ice)
- Contact
- olivier kagan
- De Novo number
- DEN250067
- Product code
- SJA
- Regulation
- 888.3048
- Classification name
- injectable for thermal treatment of musculoskeletal pain
- Decision
- granted (DENG)
- Decision date
- 2026-08-21
- Date received
- 2025-12-15
- Classification advisory
- Orthopedic
- Review advisory
- Orthopedic
- Type
- Direct