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510(k) Data Aggregation
(328 days)
NEW REGULATION NUMBER: 21 CFR 890.3780
CLASSIFICATION: Class II
PRODUCT CODE: SEC
Product Code:** SEC
Device Type: Wearable fall injury prevention device
Regulation Number: 21 CFR 890.3780
The 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)) 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.
The Tango Belt is a wearable belt designed to protect at risk older adults (65+ years of age) at risk for fall injury by reducing the risk of hip dislocation or hip fracture due to falls. A fall that results in hip dislocation or hip fracture is considered a serious hip-impacting fall.
The Tango Belt can detect a serious hip-impacting fall while in progress using built-in sensors and deploy an airbag to physically protect the hip region from impact forces. When connected to Wi-Fi, the Tango Belt can send automated fall and impact alerts to caregivers and Healthcare Providers (HCPs) while recording motion and event data, which can then be analyzed for usage-based metrics viewable via a mobile or desktop Companion App. The Tango Belt can also send manually activated alerts for help, triggered by pressing a button on the belt buckle, when connected to Wi-Fi. Alerts are sent in the form of SMS texts and emails to alert recipients designated in the mobile or desktop Companion App. The Tango Belt can also detect non-serious hip-impacting or non-hip impacting falls in which the wearer may have incurred a minor injury (i.e., not a major hip injury) and/or may be unable to get up.
The Tango Belt has three components: (1) the Smartbelt, (2) the Companion App, and (3) the Cloud Platform.
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Smartbelt: The main functionalities of the Smartbelt include gathering motion and use data; detecting a serious hip-impacting fall in progress; deploying the protective airbag; detecting non-serious hip-impacting or non-hip impacting falls; and triggering alerts, which are sent using AWS Simple Email Service to caregivers and HCPs, i.e., pre-defined contacts. The Smartbelt is solely responsible for clinical function and can perform clinical function even when not connected to Wi-Fi. It is provided in five sizes (XS, S, M, L, and XL).
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Companion App: The Companion App is used to connect the belt to Wi-Fi networks, set Wi-Fi credentials, adjust local user interface intensity, set contact details for notifications, view usage information, link belts to patients, and enable/disable certain informational notifications (status regarding if the belt is buckled, if the belt is unbuckled, or if the battery is low).
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Cloud Platform with Desktop Application: The motion and event data recorded and stored within the Smartbelt is periodically (any time the Smartbelt is placed on the charger, and once an hour if it is not on the charger if connected to Wi-Fi) uploaded to the Cloud Platform. The data is then automatically processed by the cloud-based software to capture and compute usage and compliance data. In addition, the Cloud Platform is used for the following:
- data uploads
- data storage
- Firmware over-the-air (OTA)
- Account access controls
- event logs (diagnostics)
- Manufacturer alert notification settings
- Global/Account dashboard configuration
- Developer tools
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