OIZ

Foot Examination Tool For Inflammatory Changes

产品代码

OIZ

器械名称

Foot Examination Tool For Inflammatory Changes

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 890.5050

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）

该代码近三年的 510(k)

2 件

FDA 分类定义

Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. The device will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. Intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

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）。