Home / 510(k) Clearances / DEN240021

510(k) DEN240021

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)) by Active Protective Technologies, Inc. — Product Code SEC

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: April 9, 2025
Date Received: May 16, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wearable Fall Injury Prevention Device
Device Class: Class II
Regulation Number: 890.3780
Review Panel: PM
Submission Type

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.