Tango Belt

Primary DI
00860013481315
Brand
Tango Belt
Company
Active Protective Technologies, Inc.
Model
SAS-001-02 rev. 03
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.
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SECWearable Fall Injury Prevention Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SECWearable Fall Injury Prevention DevicePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240021000Tango® 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.2025-04-09SEC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013481315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013481315008600134813158600134813150860013481315

GMDN Terms#

Term, Definition table
TermDefinition
Fall response protective beltA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1001Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Do 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
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
215-399-9763support@tangobelt.com

Regulatory Flags#

DUNS number
082498016
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013481308Tango BeltSAS-001-01 rev. 032026-02-13
00860013481322Tango BeltSAS-001-03 rev. 032026-02-13
00860013481339Tango BeltSAS-001-04 rev. 032026-02-13
00860013481353Tango BeltSAS-001-05 rev. 032026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013481308Tango BeltActive Protective Technologies, Inc.SEC2026-02-13
00860013481322Tango BeltActive Protective Technologies, Inc.SEC2026-02-13
00860013481339Tango BeltActive Protective Technologies, Inc.SEC2026-02-13
00860013481353Tango BeltActive Protective Technologies, Inc.SEC2026-02-13