IMK

Wheelchair, Stair Climbing

产品代码

IMK

器械名称

Wheelchair, Stair Climbing

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 890.3890

FDA 专业组

Physical Medicine

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

3 件

FDA 分类定义

A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2025-01-30。