# 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))

- Pathway: De Novo (Direct)
- Applicant: Active Protective Technologies, Inc.
- Decided: Apr 9, 2025 after 328 days
- Product code: SEC (Wearable Fall Injury Prevention Device)
- Device class: 2
- Regulation: 21 CFR 890.3780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Tango® Belt is indicated as an adjunctive to standard-of-care to reduce the risk of hip fracture or hip dislocation due to falls in older adults at risk of major hip injury due to falls. It is for prescription use only.

Source page: https://510kreport.com/device/DEN240021
Methodology: https://510kreport.com/methodology