QWD
- 产品代码
- QWD
- 器械名称
- Stimulator, Nerve, For Restless Legs Syndrome
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 882.5887
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 1 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.
FDA 官方分类页: QWD
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。