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INI

Vehicle, Motorized 3-Wheeled

Product code
INI
Device name
Vehicle, Motorized 3-Wheeled
Device class
Class 2
21 CFR
21 CFR 890.3800
Medical specialty
Physical Medicine
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
351

510(k) clearances, last 3 years (40)

Last three years. Most recent: 2026-08-10.

NumberDecision dateApplicantDevice name
K2600942026-08-10Zhejiang Innuovo Rehabilitation DeviceMobility Scooter (W3465, W3902 (S50 Carbon))
K2601762026-08-10Zhejiang Innuovo Rehabilitation DeviceMobility Scooter (W3483, W3483A)
K2612322026-07-14Jochu Technology Co., Ltd.IERO Mobility Scooter (IERO-01) summary
K2611632026-07-07Yongkang Ruihe Metal Product Co., Ltd.Mobility Scooter (R200) summary
K2532572026-06-08Jiangsu Intco Medical Products Co., LtVirgo Mobility Scooter (Virgo-D,Virgo-F) summary
K2536002026-06-03Yurob Rehabilitation Medical Co., Ltd.Scooter (YD-03) summary
K2607172026-05-20Suzhou Sweetrich Vehicle Industry TechMobility Scooter (Air Carbon) summary
K2602372026-04-22Wuyi Aichi Industry and Trade Co., LtdMobility Scooter (X-12, X-14, X-17) summary
K2528132026-03-17Lerado Zhongshan Peaceful Cove BusinesElectrical Scooter (SM4226) summary
K2539362026-03-12Nanjing Mijo Technology Co., Ltd.Power Mobility Scooter (MJMA01, MJMA02) summary
K2536312026-02-23Zhejiang Wei Ling New Energy TechnologMobility Scooter (CL-Q3, CL-Q4) summary
K2536432026-02-18Shenzhen Zhimahuaerkai Technology Co.,Mobility Scooter (S3)
K2523492026-01-29Dongguan Smarfody Mobility Technology Electric Scooter (Mojo-T330) summary
K2523472026-01-29Dongguan Smarfody Mobility Technology Electric Scooter (Mojo-T580) summary
K2522752026-01-29Zhejiang Nysin Medical Co., Ltd.Electric Scooter (DDF100) summary
K2530752026-01-09Suzhou Sweetrich Vehicle Industry TechMobility scooter (Air Classic); Mobility scooter (Ai summary
K2528172026-01-02Ningbo Baichen Medical Devices Co., LtMobility Scooter (BC-MS310) summary
K2528352025-12-23Guangdong Prestige Technology Co., LtdElectric Scooter (S202572J, S2060, M2089, S2050) summary
K2525882025-12-04Zhejiang Taotao Vehicle Co., Ltd.Mobility Scooter (T5) summary
K2525902025-11-21Intradin (Shanghai) Machinery Co., LtdPowered Mobility Scooter (PMS105, GUT177, GCAT047) summary
K2525022025-10-06Nanjing Kangni Smart Technology Co., LFolding Mobility Scooter (KD101) summary
K2517992025-09-30Jiangsu Bangbang Intelligent TechnologMobility Scooter (BBR-Q40-01); Mobility Scooter (BBR
K2516382025-07-22Suzhou Master Machinery Manufacturing Mobility Scooter (MS160C) summary
K2431022025-06-18Jiangxi Jiangte Electric Vehicle Co., Mobility Scooter (JT10) summary
K2505332025-05-14Taizhou Reach Technology Co., Ltd.Magnesium alloy scooter (RS100) summary
K2429752025-05-07Wuyi Aichi Industry & Trade Co., Ltd.Mobility Scooter (Model X-01, X-02) summary
K2500272025-02-21Intradin (Shanghai) Machinery Co., LtdPowered Mobility Scooter
K2429822025-01-31Suzhou Master Machinery Manufacturing Mobility Scooter (MS160A) summary
K2427142025-01-23Zhejiang Seedream Medical Equipment CoMobility Scooter (S-01); Mobility Scooter (S-02)
K2405902025-01-08W'U'S Tech Co., Ltd.Electrical Scooter, WT-T4SU summary
K2427602025-01-06Whill, Inc.WHILL Model R summary
K2421392025-01-06Yongkang Yile Vehicle Co., Ltd.Mobility Scooter (YL-09B, YL-07)
K2426282024-12-20Lichtmega Technology Co., Ltd.Scooter (PS30) summary
K2423872024-10-11Zhejiang Innuovo Rehabilitation DeviceMobility Scooter (N3473) summary
K2409902024-09-10Zhejiang Innuovo Rehabilitation DeviceMobility Scooter
K2326922024-09-05Intradin (Shanghai) Machinery Co., LtdPowered Mobility Scooter (Models: PMS101, GUT112, PM summary
K2402722024-07-16Guangdong Prestige Technology Co., LtdElectric Scooter (M2085, S2091)
K2400082024-06-05Zhejiang Innuovo Rehabilitation DeviceMobility Scooter (W3331) summary
K2400122024-05-02Zhejiang Innuovo Rehabilitation DeviceMobility Scooter (W3431) summary
K2340982024-04-18Yongkang Yile Vehicle Co., Ltd.Mobility Scooter (C4+) summary
Official FDA classification page: INI
Classification and pathway per current FDA publications. Data from openFDA (CC0).