PCD

Powered Stairway Chair Lift

产品代码
PCD
器械名称
Powered Stairway Chair Lift
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 890.5150
FDA 专业组
Physical Medicine
上市路径
豁免 510(k)(仍须遵守通用控制与注册列名)

FDA 分类定义

A powered patient stairway chair lift (Stair Machine) is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway

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)。

FDA 官方分类页: PCD
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。