FDA has a device category called wearable fall-injury-prevention devices. Compare the exact product and claim with its FDA record; do not extend one device's classification to every watch or alert system.
FDA has a product category named “wearable fall injury prevention device.” That classification should be read together with the record for the exact device, requester, intended use, and model.
FDA record example
| Record field | FDA entry |
|---|---|
| Device name | Tango Belt |
| Generic category | Wearable fall injury prevention device |
| De Novo number | DEN240021 |
| Product code | SEC |
| Decision | Granted |
| Decision date | April 9, 2025 |
The FDA’s De Novo record for the Tango Belt identifies this specific product and its classification. The SEC product-code entry describes the generic device category.
Check a product’s record
- Write down the device name, manufacturer, model, and stated fall-related function.
- Search FDA’s De Novo and product-classification records by product name or product code.
- Compare the manufacturer and model in the record with the product page or label.
- Read the device’s stated intended use and decision status.
- Check for a distinct record when the product combines an alert service, watch, sensor, or fall-related feature.
- Treat the record as device-specific and do not transfer it to a different product.
For other wearable regulatory records, compare Apple Watch ECG record details and pulse oximeter classification codes. Browse aging and safety devices.
This page describes a device category and FDA records. Speak with a doctor about health concerns or questions about using a medical device.
Sources
Common questions
Does the FDA wearable fall-injury-prevention category cover every fall alert?
No. Check the exact device, requester, intended use, and FDA record.
What is product code SEC?
FDA uses SEC for the generic category wearable fall-injury-prevention device.
Is an FDA record for one wearable a record for another brand?
No. Match each product to its own device name, manufacturer, and regulatory record.