INI
- 产品代码
- INI
- 器械名称
- Vehicle, Motorized 3-Wheeled
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 890.3800
- FDA 专业组
- Physical Medicine
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 40 件
- 其中 Summary 已存档
- 30 份，可直接下载
- FDA 历史累计 510(k)
- 351 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（40 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260094 | 2026-08-10 | Zhejiang Innuovo Rehabilitation Device… | Mobility Scooter (W3465, W3902 (S50 Carbon)) | — |
| K260176 | 2026-08-10 | Zhejiang Innuovo Rehabilitation Device… | Mobility Scooter (W3483, W3483A) | — |
| K261232 | 2026-07-14 | Jochu Technology Co., Ltd. | IERO Mobility Scooter (IERO-01) | |
| K261163 | 2026-07-07 | Yongkang Ruihe Metal Product Co., Ltd. | Mobility Scooter (R200) | |
| K253257 | 2026-06-08 | Jiangsu Intco Medical Products Co., Lt… | Virgo Mobility Scooter (Virgo-D,Virgo-F) | |
| K253600 | 2026-06-03 | Yurob Rehabilitation Medical Co., Ltd. | Scooter (YD-03) | FDA |
| K260717 | 2026-05-20 | Suzhou Sweetrich Vehicle Industry Tech… | Mobility Scooter (Air Carbon) | |
| K260237 | 2026-04-22 | Wuyi Aichi Industry and Trade Co., Ltd… | Mobility Scooter (X-12, X-14, X-17) | |
| K252813 | 2026-03-17 | Lerado Zhongshan Peaceful Cove Busines… | Electrical Scooter (SM4226) | |
| K253936 | 2026-03-12 | Nanjing Mijo Technology Co., Ltd. | Power Mobility Scooter (MJMA01, MJMA02) | |
| K253631 | 2026-02-23 | Zhejiang Wei Ling New Energy Technolog… | Mobility Scooter (CL-Q3, CL-Q4) | |
| K253643 | 2026-02-18 | Shenzhen Zhimahuaerkai Technology Co.,… | Mobility Scooter (S3) | — |
| K252349 | 2026-01-29 | Dongguan Smarfody Mobility Technology … | Electric Scooter (Mojo-T330) | |
| K252347 | 2026-01-29 | Dongguan Smarfody Mobility Technology … | Electric Scooter (Mojo-T580) | |
| K252275 | 2026-01-29 | Zhejiang Nysin Medical Co., Ltd. | Electric Scooter (DDF100) | |
| K253075 | 2026-01-09 | Suzhou Sweetrich Vehicle Industry Tech… | Mobility scooter (Air Classic); Mobility scooter (Ai… | |
| K252817 | 2026-01-02 | Ningbo Baichen Medical Devices Co., Lt… | Mobility Scooter (BC-MS310) | |
| K252835 | 2025-12-23 | Guangdong Prestige Technology Co., Ltd… | Electric Scooter (S202572J, S2060, M2089, S2050) | |
| K252588 | 2025-12-04 | Zhejiang Taotao Vehicle Co., Ltd. | Mobility Scooter (T5) | |
| K252590 | 2025-11-21 | Intradin (Shanghai) Machinery Co., Ltd… | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | |
| K252502 | 2025-10-06 | Nanjing Kangni Smart Technology Co., L… | Folding Mobility Scooter (KD101) | |
| K251799 | 2025-09-30 | Jiangsu Bangbang Intelligent Technolog… | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR… | — |
| K251638 | 2025-07-22 | Suzhou Master Machinery Manufacturing … | Mobility Scooter (MS160C) | |
| K243102 | 2025-06-18 | Jiangxi Jiangte Electric Vehicle Co., … | Mobility Scooter (JT10) | |
| K250533 | 2025-05-14 | Taizhou Reach Technology Co., Ltd. | Magnesium alloy scooter (RS100) | |
| K242975 | 2025-05-07 | Wuyi Aichi Industry & Trade Co., Ltd. | Mobility Scooter (Model X-01, X-02) | |
| K250027 | 2025-02-21 | Intradin (Shanghai) Machinery Co., Ltd… | Powered Mobility Scooter | — |
| K242982 | 2025-01-31 | Suzhou Master Machinery Manufacturing … | Mobility Scooter (MS160A) | |
| K242714 | 2025-01-23 | Zhejiang Seedream Medical Equipment Co… | Mobility Scooter (S-01); Mobility Scooter (S-02) | — |
| K240590 | 2025-01-08 | W'U'S Tech Co., Ltd. | Electrical Scooter, WT-T4SU | |
| K242760 | 2025-01-06 | Whill, Inc. | WHILL Model R | |
| K242139 | 2025-01-06 | Yongkang Yile Vehicle Co., Ltd. | Mobility Scooter (YL-09B, YL-07) | — |
| K242628 | 2024-12-20 | Lichtmega Technology Co., Ltd. | Scooter (PS30) | |
| K242387 | 2024-10-11 | Zhejiang Innuovo Rehabilitation Device… | Mobility Scooter (N3473) | |
| K240990 | 2024-09-10 | Zhejiang Innuovo Rehabilitation Device… | Mobility Scooter | — |
| K232692 | 2024-09-05 | Intradin (Shanghai) Machinery Co., Ltd… | Powered Mobility Scooter (Models: PMS101, GUT112, PM… | |
| K240272 | 2024-07-16 | Guangdong Prestige Technology Co., Ltd… | Electric Scooter (M2085, S2091) | — |
| K240008 | 2024-06-05 | Zhejiang Innuovo Rehabilitation Device… | Mobility Scooter (W3331) | |
| K240012 | 2024-05-02 | Zhejiang Innuovo Rehabilitation Device… | Mobility Scooter (W3431) | |
| K234098 | 2024-04-18 | Yongkang Yile Vehicle Co., Ltd. | Mobility Scooter (C4+) |
FDA 官方分类页： INI
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。