Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

QOL · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 890.5420

Classification

FDA Product Code: QOL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.5420
Review panel: PM
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.

Market data

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

Source

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