QTC
- 产品代码
- QTC
- 器械名称
- Adult Portable Bed Rails For Medical Purposes
- 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）
FDA 分类定义
An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics.
FDA 官方分类页： QTC
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。