SEC
- Product code
- SEC
- Device name
- Wearable Fall Injury Prevention Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.3780
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 0 (direct download)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| DEN240021 | 2025-04-09 | Active Protective Technologies, Inc. | Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02… | — |
Official FDA classification page: SEC
Classification and pathway per current FDA publications. Data from openFDA (CC0).