QGT
- 产品代码
- QGT
- 器械名称
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 882.5899
- FDA 专业组
- Neurology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 3 件
- 其中 Summary 已存档
- 3 份,可直接下载
- FDA 历史累计 510(k)
- 7 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
该代码近三年的 510(k)(3 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K250405 | 2025-05-14 | Theranica Bio-Electronics, Ltd. | Nerivio; Nerivio Infinity | |
| K241756 | 2024-10-08 | Theranica Bio-Electronics, Ltd. | Nerivio; NerivioInfinity | |
| K232152 | 2023-11-08 | Theranica Bioelectronics , Ltd. | NerivioInfinity |
FDA 官方分类页: QGT
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。