NHF
- 产品代码
- NHF
- 器械名称
- Monitor, Orthotic/Prosthetic
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 890.3025
- 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）
- 标记
- 豁免 GMP（质量体系）
FDA 分类定义
A monitor, orthotic/prosthetic is a non-invasive, battery-powered, data storage accessory device that is attached to or embedded in medical appliances such as splints, braces, orthotics, prosthetics, and wearable exercise devices, to record how often the appliance is worn, through the use of sensors that record changes in temperature, motion, skin proximity, etc.
FDA 官方分类页： NHF
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。