| 产品名称 | 电动轮椅车 |
|---|---|
| 结构及组成/主要组成成分 | 电动轮椅车由靠背、上控器、坐垫、车轮、脚踏板、扶手、车架、电机、电池、电机控制器和适配器组成，附件：置物篮、照明灯、安全带。 |
| 适用范围/预期用途 | 供残疾人或无完全行走能力者代步使用，产品仅乘载1人且使用者质量不超过100kg。 |
| 型号规格 | RN-1A3A、RN-1B3A、RN-1C3A、RN-1A4A、RN-1B4A、RN-1C4A、RN-1A5A、RN-1B5A、RN-1C5A、RN-2A3A、RN-2B3A、RN-2C3A、RN-2A4A、RN-2B4A、RN-2C4A、RN-2A5A、RN-2B5A、RN-2C5A、RW-1A1A、RW-1B1A、RW-1C1A、RW-1A2A、RW-1B2A、RW-1C2A、RW-2A1A、RW-2B1A、RW-2C1A、、RW-2A2A、RW-2B2A、RW-2C2ARN-1A3AT、RN-1B3AT、RN-1C3AT、RN-1A4AT、RN-1B4AT、RN-1C4AT、RN-1A5AT、RN-1B5AT、RN-1C5AT、RN-2A3AT、RN-2B3AT、RN-2C3AT、RN-2A4AT、RN-2B4AT、RN-2C4AT、RN-2A5AT、RN-2B5AT、RN-2C5AT、RW-1A1AT、RW-1B1AT、RW-1C1AT、RW-1A2AT、RW-1B2AT、RW-1C2AT、RW-2A1AT、RW-2B1AT、RW-2C1AT、RW-2A2AT、RW-2B2AT、RW-2C2AT、RN-1A3B、RN-1B3B、RN-1C3B、RN-1A4B、RN-1B4B、RN-1C4B、RN-1A5B、RN-1B5B、RN-1C5B、RN-2A3B、RN-2B3B、RN-2C3B、RN-2A4B、RN-2B4B、RN-2C4B、RN-2A5B、RN-2B5B、RN-2C5B、RW-1A1B、RW-1B1B、RW-1C1B、RW-1A2B、RW-1B2B、RW-1C2B、RW-2A1B、RW-2B1B、RW-2C1B、、RW-2A2B、RW-2B2B、RW-2C2B、RN-1A3BT、RN-1B3BT、RN-1C3BT、RN-1A4BT、RN-1B4BT、RN-1C4BT、RN-1A5BT、RN-1B5BT、RN-1C5BT、RN-2A3BT、RN-2B3BT、RN-2C3BT、RN-2A4BT、RN-2B4BT、RN-2C4BT、RN-2A5BT、RN-2B5BT、RN-2C5BT、RW-1A1BT、RW-1B1BT、RW-1C1BT、RW-1A2BT、RW-1B2BT、RW-1C2BTRW-2A1BT、RW-2B1BT、RW-2C1BT、、RW-2A2BT、RW-2B2BT、RW-2C2BT |
| 产品储存条件及有效期 | 不适用。 |
| 注册证编号 | 苏械注准20232191036 |
| 注册人名称 | 江苏瑞布特智能科技有限公司 |
| 注册人住所 | 江苏省常州市天宁区弘仁路2号1号楼301室 |
| 生产地址 | 江苏省常州市天宁区弘仁路2号1号楼1层、3层、4层 |
| 备注 | 本文件与“苏械注准20232191036”医疗器械注册证共同使用 |
| 批准日期 | 2024-06-18 |
| 有效期至 | 2028-07-20 |
| 变更情况 | 2024-06-18型号、规格变更 由“RW-1A1A、RW-1B1A、RW-1C1A、RW-1A2A、RW-1B2A、RW-1C2ARW-2A1A、RW-2B1A、RW-2C1A、、RW-2A2A、RW-2B2A、RW-2C2A、RN-1A3A、RN-1B3A、RN-1C3A、RN-1A4A、RN-1B4A、RN-1C4A、RN-1A5A、RN-1B5A、RN-1C5A、RN-2A3A、RN-2B3A、RN-2C3A、RN-2A4A、RN-2B4A、RN-2C4A、RN-2A5A、RN-2B5A、RN-2C5A、RW-1A1B、RW-1B1B、RW-1C1B、RW-1A2B、RW-1B2B、RW-1C2BRW-2A1B、RW-2B1B、RW-2C1B、、RW-2A2B、RW-2B2B、RW-2C2B、RN-1A3B、RN-1B3B、RN-1C3B、RN-1A4B、RN-1B4B、RN-1C4B、RN-1A5B、RN-1B5B、RN-1C5B、RN-2A3B、RN-2B3B、RN-2C3B、RN-2A4B、RN-2B4B、RN-2C4B、RN-2A5B、RN-2B5B、RN-2C5B”变更为“RN-1A3A、RN-1B3A、RN-1C3A、RN-1A4A、RN-1B4A、RN-1C4A、RN-1A5A、RN-1B5A、RN-1C5A、RN-2A3A、RN-2B3A、RN-2C3A、RN-2A4A、RN-2B4A、RN-2C4A、RN-2A5A、RN-2B5A、RN-2C5A、RW-1A1A、RW-1B1A、RW-1C1A、RW-1A2A、RW-1B2A、RW-1C2A、RW-2A1A、RW-2B1A、RW-2C1A、、RW-2A2A、RW-2B2A、RW-2C2ARN-1A3AT、RN-1B3AT、RN-1C3AT、RN-1A4AT、RN-1B4AT、RN-1C4AT、RN-1A5AT、RN-1B5AT、RN-1C5AT、RN-2A3AT、RN-2B3AT、RN-2C3AT、RN-2A4AT、RN-2B4AT、RN-2C4AT、RN-2A5AT、RN-2B5AT、RN-2C5AT、RW-1A1AT、RW-1B1AT、RW-1C1AT、RW-1A2AT、RW-1B2AT、RW-1C2AT、RW-2A1AT、RW-2B1AT、RW-2C1AT、RW-2A2AT、RW-2B2AT、RW-2C2AT、RN-1A3B、RN-1B3B、RN-1C3B、RN-1A4B、RN-1B4B、RN-1C4B、RN-1A5B、RN-1B5B、RN-1C5B、RN-2A3B、RN-2B3B、RN-2C3B、RN-2A4B、RN-2B4B、RN-2C4B、RN-2A5B、RN-2B5B、RN-2C5B、RW-1A1B、RW-1B1B、RW-1C1B、RW-1A2B、RW-1B2B、RW-1C2B、RW-2A1B、RW-2B1B、RW-2C1B、、RW-2A2B、RW-2B2B、RW-2C2B、RN-1A3BT、RN-1B3BT、RN-1C3BT、RN-1A4BT、RN-1B4BT、RN-1C4BT、RN-1A5BT、RN-1B5BT、RN-1C5BT、RN-2A3BT、RN-2B3BT、RN-2C3BT、RN-2A4BT、RN-2B4BT、RN-2C4BT、RN-2A5BT、RN-2B5BT、RN-2C5BT、RW-1A1BT、RW-1B1BT、RW-1C1BT、RW-1A2BT、RW-1B2BT、RW-1C2BTRW-2A1BT、RW-2B1BT、RW-2C1BT、、RW-2A2BT、RW-2B2BT、RW-2C2BT”产品技术要求变更 由“技术要求变更情况对比表原条款及内容”变更为“技术要求变更情况对比表修改后条款及内容” |
| 编码代号2018 | 暂无权限 |
| 管理分类 | Ⅱ |
| 企业联系电话 | 暂无权限 |
| 指导原则 | 暂无权限 |
| 相关标准 | 暂无权限 |
| 临床路径 | 暂无权限 |
| 共性问题 | 暂无权限 |
国产器械智能分析
国产器械智能分析
暂无权限！更多信息，升级会员权限，立即享受
电动轮椅车
