SEC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Wearable Fall Injury Prevention Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3780
- Medical specialty
- Physical Medicine
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| 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)) (DEN240021) | Active Protective Technologies, Inc. | 2025-04-09 |
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