SOURCE RECORD / S0201

FDA De Novo DEN200046：Neurolutions 上肢康复系统分类记录

证据 A

FDA De Novo DEN200046 — Neurolutions Upper Extremity Rehabilitation System

作者或机构: U.S. Food and Drug Administration
发布日期: 2021-04-23
来源类型: regulatory_database_record
技术路线: non-invasive EEG-driven upper-extremity powered exerciser
功能场景: stroke rehabilitation regulation
权利状态: manual_review

证据摘要

证据支持：美国对非侵入式 EEG 驱动上肢训练设备的监管分类事实。关键数字：DEN200046、product code QOL、Class II、21 CFR 890.5420、决定日期 2021-04-23、implant flag N。局限：这不是中国批准、比较疗效、当前在售状态或所有脑机接口康复产品的通用路径；openFDA 也提示 API 数据未经验证。

关键数字

DEN200046; product code QOL; Class II; 21 CFR 890.5420; decision date 2021-04-23; implant flag N

局限

U.S. regulatory fact only; not Chinese approval, comparative effectiveness, current sales status, or evidence that all BCI rehabilitation products share this pathway; openFDA warns its API data are unvalidated

原始链接