Product code SEC
- Device name
- Wearable Fall Injury Prevention Device
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.3780
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN240021 | 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)) | Active Protective Technologies, Inc. | 2025-04-09 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00860013481308 | Tango Belt | Active Protective Technologies, Inc. | 2026-02-13 |
| 00860013481315 | Tango Belt | Active Protective Technologies, Inc. | 2026-02-13 |
| 00860013481322 | Tango Belt | Active Protective Technologies, Inc. | 2026-02-13 |
| 00860013481339 | Tango Belt | Active Protective Technologies, Inc. | 2026-02-13 |
| 00860013481353 | Tango Belt | Active Protective Technologies, Inc. | 2026-02-13 |