ILK
- 产品代码
- ILK
- 器械名称
- Transport, Patient, Powered
- 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
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 36 件
FDA 分类定义
A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
该代码近三年的 510(k)（1 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K240843 | 2024-10-07 | Climbing Steps, Inc. | GENESIS (MS-P02-GEN) |
FDA 官方分类页： ILK
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。