Wearable Fall Injury Prevention Device
A wearable fall injury prevention device is a physical medicine device intended to detect falls and prevent major fall injuries by deploying a protective mechanism upon fall detection to reduce the risk of injury, particularly for at-risk populations such as elderly individuals or those with balance disorders. It is classified as FDA Class II (510(k) required) under regulation 890.3780 in the Physical Medicine specialty, with product code SEC. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SEC
- Device Class
- FDA class 2
- Regulation Number
- 890.3780
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| 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)) | Apr 09, 2025 | Unknown | Active Protective Technologies, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.