QOL

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

产品代码

QOL

器械名称

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 890.5420

FDA 专业组

Neurology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。