IOR

Wheelchair, Mechanical

产品代码

IOR

器械名称

Wheelchair, Mechanical

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 890.3850

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)

463 件

FDA 分类定义

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. 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/or 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)（26 件）

数据窗口为最近三年。最新一件：2026-08-06。