DeviceClearance

Product code SEC— Physical Medicine

Tango® Belt (Model SAS-001-01 (XS) +4 more

Classification name
Wearable Fall Injury Prevention Device
Device class
Class 2
Regulation
21 CFR 890.3780
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SEC under 21 CFR 890.3780, via openFDA

Market context for product code SEC

FDA has cleared 1 device under product code SEC, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEC

Recent clearances under product code SEC

Data sourced from openFDA. This site is unofficial and independent of the FDA.