510(k) DEN240021
DEN240021 is an FDA 510(k) premarket notification submitted by Active Protective Technologies, Inc. for the 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))". The FDA issued a decision of De Novo Granted on April 9, 2025. The device falls under product code SEC (Wearable Fall Injury Prevention Device), a Class II device regulated under 21 CFR 890.3780.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 9, 2025
- Date Received
- May 16, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wearable Fall Injury Prevention Device
- Device Class
- Class II
- Regulation Number
- 890.3780
- Review Panel
- PM
- Submission Type
A wearable fall injury prevention device is intended to detect falls and prevent major fall injuries. Once a fall is detected, the device deploys a protective mechanism to reduce the risk of injury.