Wearable Fall Injury Prevention Device

SEC · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3780

Classification

FDA Product Code: SEC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.3780
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown