Tango Belt

Basic Information

• Brand Name: Tango Belt
• Primary DI: 00860013481353
• Version / Model: SAS-001-05 rev. 03
• Company Name: Active Protective Technologies, Inc.
• Labeler DUNS: 082498016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-13
• Public Version: 1
• Public Version Date: 2026-02-23
• Public Version Status: New
• Public Device Record Key: 2e27bfb8-2501-465d-af01-e61ef128e77e

Device Description

The Tango® Belt is a device worn around the waist and uses built-in sensors and algorithms to detect an in-progress serious hip-impacting fall and deploy an airbag. The device can also send an information notice to the designed caregiver/healthcare provider(s) upon detection of a fall or impact when the device is connected to WiFi.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SEC	Wearable Fall Injury Prevention Device	Physical Medicine	890.3780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67545	Fall response protective belt	A battery-powered multi-purpose device intended to be worn around the waist by a vulnerable person to: 1) detect in-progress, laterally-impacting falls and deploy an airbag-like guard to reduce the risk of hip injury (e.g., fracture, dislocation); 2) remotely alert caregivers (e.g., via the internet or other network) whilst providing local audio, visual and haptic alerts; 3) record event data (e.g., falls, patient balance); and 4) allow a patient to manually initiate an alert signal for help. It includes balance sensors/accelerometers, wireless network features, user controls (e.g., via a smart device app), a call button, and deployable inflatable hip protectors. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013481353	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN240021	000

Device Sizes

Type	Value	Unit	Text
Length	1373	Millimeter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not buckle when not worn. Do not expose to flames. Do not wear while bathing. Should be wiped with recommended disinfectant wipe between uses. Do not use if internally soiled. Do not use if de