SEC

Wearable Fall Injury Prevention Device

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-09.

NumberDecision dateApplicantDevice nameSummary
DEN2400212025-04-09Active 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).