Not Cleared Direct

DEN240021 - Tango® Belt (Model SAS-001-01 (XS) (FDA 510(k) Clearance)

Also includes:
Model SAS-001-02 (S) Model SAS-001-03 (M) Model SAS-001-04 (L) Model SAS-001-05 (XL))

Class II Physical Medicine device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN240021 · Active Protective Technologies, Inc. · Physical Medicine device
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Apr 2025
Decision
328d
Days
Class 2
Risk

DEN240021 is an FDA 510(k) submission (not cleared) for the Tango® Belt (Model SAS-001-01 (XS). Classified as Wearable Fall Injury Prevention Device (product code SEC), Class II - Special Controls.

Submitted by Active Protective Technologies, Inc. (Fort Washington, US). The FDA issued a Not Cleared (DENG) decision on April 9, 2025 after a review of 328 days.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3780 - the FDA physical medicine device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 328 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Active Protective Technologies, Inc. devices

Submission Details

510(k) Number DEN240021 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 16, 2024
Decision Date April 09, 2025
Days to Decision 328 days
Submission Type Direct
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 115d · This submission: 328d
Pathway characteristics

Device Classification

Product Code SEC Wearable Fall Injury Prevention Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3780
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.