SEC · Wearable Fall Injury Prevention Device
Physical Medicine · 21 CFR 890.3780 · Class 2
Overview
| Product Code | SEC |
|---|---|
| Device Name | Wearable Fall Injury Prevention Device |
| Regulation | 21 CFR 890.3780 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
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. The Tango Belt is a wearable belt designed to protect at-risk older adults (65+ years of age) by reducing the risk of hip dislocation or hip fracture due to falls. It detects serious hip-impacting falls in progress using built-in sensors and deploys an airbag to physically protect the hip region. It also provides automated fall and impact alerts to caregivers and Healthcare Providers via Wi-Fi and a Companion App.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, with the determination that the probable benefits outweigh the probable risks when mitigated by general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the wearable fall injury prevention device is subject to the following special controls: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Deployment of protection measures in the case of a fall; (ii) Deployment rate when a fall is not occurring; and (iii) Device durability. (2) Software verification, validation, and hazard analysis must be performed. (3) Performance testing must demonstrate the electromagnetic compatibility (EMC), electrical safety, and battery performance and safety of the device. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Labeling for the user must include: (i) Instructions on fitting the device to the user; (ii) Information on how the device operates and the typical sensations experienced during use; and (iii) Cleaning instructions.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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)) | Active Protective Technologies, Inc. | Apr 9, 2025 | DENG |
Top Applicants
- Active Protective Technologies, Inc. — 1 clearance
