510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240021Unknown

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))

Active Protective Technologies, Inc., Fort Washington PA / Direct, Unknown
FDA source (opens on fda.gov)

DEN240021 is the FDA 510(k) clearance record for 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)), a class II device, cleared for Active Protective Technologies, Inc. on under FDA product code SEC (Wearable Fall Injury Prevention Device). FDA's definition for product code SEC reads: "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". FDA records list one 510(k) clearance for Active Protective Technologies, Inc. As of , FDA records show no recalls naming DEN240021.

Clearance record

Decision date
Received
(328 days to decision)
Product code
SEC Wearable Fall Injury Prevention Device
Regulation
21 CFR 890.3780
Device class
Class II
Review panel
Physical Medicine
Applicant
Active Protective Technologies, Inc. 580 Virginia Dr., Suite 230, Fort Washington PA
Third party review
No

Clearances, product code SEC

Trailing 12 months

FDA records hold no clearances under product code SEC in the trailing twelve months.

FDA records show no clearances under product code SEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SEC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260