De Novo DEN240021
- Device
- Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))
- Contact
- wamis singhatat
- De Novo number
- DEN240021
- Product code
- SEC
- Regulation
- 890.3780
- Classification name
- wearable fall injury prevention device
- Decision
- granted (DENG)
- Decision date
- 2025-04-09
- Date received
- 2024-05-16
- Classification advisory
- Physical Medicine
- Review advisory
- Physical Medicine
- Type
- Direct
Current FDA Classification#
- Product code
- SEC
- Device name
- Wearable Fall Injury Prevention Device
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation
- 890.3780
- Implant
- N
- Life sustain/support
- N