PCD
- 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
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。