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U.S. Department of Health and Human Services

Product Classification
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Device wearable fall injury prevention device
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.
Physical State The device is a belt worn around the waist by the patient over the clothes and. The belt features an air bag that deploys when a serious fall is detected.
Technical Method Uses sensors and force detectors to determine if an in-progress fall is likely to cause a serious injury. If a serious injury fall is detected, then the device deploys a protective mechanism to prevent major injuries from the fall.
Target Area Hips and waist
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeSEC
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.3780
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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