510(k) K253936

Device: Power Mobility Scooter (MJMA01, MJMA02)
Applicant: Nanjing Mijo Technology Co., Ltd.
510(k) number: K253936
Product code: INI
Decision: Substantially Equivalent (SESE)
Decision date: 2026-03-12
Date received: 2025-12-09
Regulation: 890.3800
Classification name: Vehicle, Motorized 3-Wheeled
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Leo Zhang
Address: 2nd Floor, Bldg. A3, Hongfeng Science And Technology Park Nanjing Economic And Technological Development Zone Nanjing CN

FDA Registration Numbers

9680333
3020640553
3004594214
3019842343
2531618
9616873
3016733848
1528161
3012538618
3039857114
3014489639
2531465
3022982004
3016068274
3020147377
3008597995
3042262539
1821729
3034732597
3007963811
3008717361
3006247243
3016195086
3004024088
3033905189
3012425482
3035382637
8043717
3032013112
3003820676
3037000105
8043457
3012521614
3033860076
3030671633
3043105518
3015992762
3017816603
3012604975
3015726735
9618009
3007771912
3029926469
3007675960
3006541027
3044470904
3003882673
3011191255
3008812160
3043153502
3003636180
3016969129
3012781455
3034989977
3013934051
3004142507
3026585646
3019984611
3014983822
3008841035
3007608806
3013973449
3009265647
1058069
3017676057
9616881
3021071770
3005619729

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code INI

510(k)	Device	Applicant	Decision date
K260237	Mobility Scooter (X-12, X-14, X-17)	Wuyi Aichi Industry and Trade Co., Ltd.	2026-04-22
K252813	Electrical Scooter (SM4226)	Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.	2026-03-17
K253631	Mobility Scooter (CL-Q3, CL-Q4)	Zhejiang Wei Ling New Energy Technology Co., Ltd.	2026-02-23
K253643	Mobility Scooter (S3)	Shenzhen Zhimahuaerkai Technology Co., Ltd.	2026-02-18
K252349	Electric Scooter (Mojo-T330)	Dongguan Smarfody Mobility Technology Co., Ltd.	2026-01-29
K252347	Electric Scooter (Mojo-T580)	Dongguan Smarfody Mobility Technology Co., Ltd.	2026-01-29
K252275	Electric Scooter (DDF100)	Zhejiang Nysin Medical Co., Ltd.	2026-01-29
K253075	Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)	Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.	2026-01-09
K252817	Mobility Scooter (BC-MS310)	Ningbo Baichen Medical Devices Co., Ltd.	2026-01-02
K252835	Electric Scooter (S202572J, S2060, M2089, S2050)	Guangdong Prestige Technology Co., Ltd.	2025-12-23
K252588	Mobility Scooter (T5)	Zhejiang Taotao Vehicle Co., Ltd.	2025-12-04
K252590	Powered Mobility Scooter (PMS105, GUT177, GCAT047)	Intradin (Shanghai) Machinery Co., Ltd.	2025-11-21
K252502	Folding Mobility Scooter (KD101)	Nanjing Kangni Smart Technology Co., Ltd.	2025-10-06
K251799	Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)	Jiangsu Bangbang Intelligent Technology Co., Ltd.	2025-09-30
K251638	Mobility Scooter (MS160C)	Suzhou Master Machinery Manufacturing Co.,Ltd	2025-07-22