INI — Vehicle, Motorized 3-Wheeled Class II

FDA Device Classification

Classification Details

Product Code
INI
Device Class
Class II
Regulation Number
890.3800
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253936nanjing mijo technology coPower Mobility Scooter (MJMA01, MJMA02)March 12, 2026
K253631zhejiang wei ling new energy technology coMobility Scooter (CL-Q3, CL-Q4)February 23, 2026
K253643shenzhen zhimahuaerkai technology coMobility Scooter (S3)February 18, 2026
K252347dongguan smarfody mobility technology coElectric Scooter (Mojo-T580)January 29, 2026
K252349dongguan smarfody mobility technology coElectric Scooter (Mojo-T330)January 29, 2026
K252275zhejiang nysin medical coElectric Scooter (DDF100)January 29, 2026
K253075suzhou sweetrich vehicle industry technology coMobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scootJanuary 9, 2026
K252817ningbo baichen medical devices coMobility Scooter (BC-MS310)January 2, 2026
K252835guangdong prestige technology coElectric Scooter (S202572J, S2060, M2089, S2050)December 23, 2025
K252588zhejiang taotao vehicle coMobility Scooter (T5)December 4, 2025
K252590intradin (shanghai) machinery coPowered Mobility Scooter (PMS105, GUT177, GCAT047)November 21, 2025
K252502nanjing kangni smart technology coFolding Mobility Scooter (KD101)October 6, 2025
K251799jiangsu bangbang intelligent technology coMobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (September 30, 2025
K251638suzhou master machinery manufacturing coMobility Scooter (MS160C)July 22, 2025
K243102jiangxi jiangte electric vehicle coMobility Scooter (JT10)June 18, 2025
K250533taizhou reach technology coMagnesium alloy scooter (RS100)May 14, 2025
K242975wuyi aichi industry and trade coMobility Scooter (Model X-01, X-02)May 7, 2025
K250027intradin (shanghai) machinery coPowered Mobility ScooterFebruary 21, 2025
K242982suzhou master machinery manufacturing coMobility Scooter (MS160A)January 31, 2025
K242714zhejiang seedream medical equipment coMobility Scooter (S-01); Mobility Scooter (S-02)January 23, 2025