QHH
- 产品代码
- QHH
- 器械名称
- Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 876.5340
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 4 件
- 其中 Summary 已存档
- 4 份,可直接下载
- FDA 历史累计 510(k)
- 6 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A non-implanted nerve stimulator for functional abdominal pain relief is a device that stimulates nerves remotely from the source of pain with the intent to relieve functional abdominal pain. This generic type of device does not include devices designed to relieve pelvic pain.
该代码近三年的 510(k)(4 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252024 | 2025-10-16 | Neuraxis | NeurAxis IB-Stim (01-1020) | |
| K250451 | 2025-05-15 | Neuraxis | NeurAxis IB-Stim (01-1020) | |
| K241533 | 2024-10-30 | Neuraxis | NeurAxis IB-Stim (01-1020) | |
| K230526 | 2023-09-14 | Transtimulation Research, Inc. | TEA Device |
FDA 官方分类页: QHH
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。