Product code SEC

Device name

Wearable Fall Injury Prevention Device

Medical specialty

Physical Medicine

Device class

2

Regulation number

890.3780

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset