510(k) K252817

Device: Mobility Scooter (BC-MS310)
Applicant: Ningbo Baichen Medical Devices Co., Ltd.
510(k) number: K252817
Product code: INI
Decision: Substantially Equivalent (SESE)
Decision date: 2026-01-02
Date received: 2025-09-04
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: Xiaolong Wu
Address: Rm. 2101, #666 Taikang Middle Rd., Yinzhou District Ningbo CN 315000 315000

FDA Registration Numbers

3026585646
3015992762
3042262539
3008717361
3006247243
9618009
2531465
3003882673
3019842343
3006541027
3013934051
3004142507
2531618
3016969129
3043153502
8043457
3007771912
1058069
9680333
3021071770
3007608806
3012538618
3019984611
3008841035
3038949386
3016068274
3017816603
3033905189
3007963811
3043105518
3004024088
3007675960
3044470904
1528161
3012425482
3017676057
3014983822
9616881
3009265647
3029926469
3012781455
3016733848
3004594214
3015726735
3034732597
9616873
3008812160
3013973449
1821729
3005619729
8043717
3011191255
3022982004
3037000105
3014489639
3008597995
3012521614
3020640553
3016195086
3030671633
3033860076
3032013112
3039857114
3035382637
3003636180
3034989977
3003820676
3020147377
3012604975

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code INI

510(k)	Device	Applicant	Decision date
K260717	Mobility Scooter (Air Carbon)	Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.	2026-05-20
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
K253936	Power Mobility Scooter (MJMA01, MJMA02)	Nanjing Mijo Technology Co., Ltd.	2026-03-12
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
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