FDA product code SEC: Wearable Fall Injury Prevention Device
SEC is the FDA product code for wearable fall injury prevention device. It is a Class II device, regulated under 21 CFR 890.3780 and reviewed by the Physical Medicine panel. Devices under SEC reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Wearable Fall Injury Prevention Device |
| Device class | Class II |
| Regulation | 21 CFR 890.3780 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
Recalls for SEC devices
openFDA lists no recalls for product code SEC.
Frequently asked questions
What is FDA product code SEC?
SEC is the FDA product code for wearable fall injury prevention device. It is a Class II device, regulated under 21 CFR 890.3780 and reviewed by the Physical Medicine panel.
What device class is SEC?
Class II, regulation 21 CFR 890.3780. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SEC
- Run a recall and safety report across every SEC manufacturer
- Watch product code SEC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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