DEN240021 is an FDA 510(k) submission for the Tango® Belt (Model SAS-001-01 (XS). This device is classified as a Wearable Fall Injury Prevention Device (Class II - Special Controls, product code SEC).
Submitted by Active Protective Technologies, Inc. (Fort Washington, US). The FDA issued a Not Cleared (DENG) decision on April 9, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3780. 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..
| 510(k) Number | DEN240021 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 16, 2024 |
| Decision Date | April 09, 2025 |
| Days to Decision | 328 days |
| Submission Type | Direct |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | SEC - Wearable Fall Injury Prevention Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3780 |
| Definition | 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. |