510(k) K252813

Device
Electrical Scooter (SM4226)
Applicant
Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
510(k) number
K252813
Product code
INI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-17
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
Ke-Min Jen
Address
# 26, Guangfu Rd., Xiaolan Town Zhongshan CN 528414 528414

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code INI

510(k)DeviceApplicantDecision date
K260717Mobility Scooter (Air Carbon)Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.2026-05-20
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K253936Power Mobility Scooter (MJMA01, MJMA02)Nanjing Mijo Technology Co., Ltd.2026-03-12
K253631Mobility Scooter (CL-Q3, CL-Q4)Zhejiang Wei Ling New Energy Technology Co., Ltd.2026-02-23
K253643Mobility Scooter (S3)Shenzhen Zhimahuaerkai Technology Co., Ltd.2026-02-18
K252349Electric Scooter (Mojo-T330)Dongguan Smarfody Mobility Technology Co., Ltd.2026-01-29
K252347Electric Scooter (Mojo-T580)Dongguan Smarfody Mobility Technology Co., Ltd.2026-01-29
K252275Electric Scooter (DDF100)Zhejiang Nysin Medical Co., Ltd.2026-01-29
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K252817Mobility Scooter (BC-MS310)Ningbo Baichen Medical Devices Co., Ltd.2026-01-02
K252835Electric Scooter (S202572J, S2060, M2089, S2050)Guangdong Prestige Technology Co., Ltd.2025-12-23
K252588Mobility Scooter (T5)Zhejiang Taotao Vehicle Co., Ltd.2025-12-04
K252590Powered Mobility Scooter (PMS105, GUT177, GCAT047)Intradin (Shanghai) Machinery Co., Ltd.2025-11-21
K252502Folding Mobility Scooter (KD101)Nanjing Kangni Smart Technology Co., Ltd.2025-10-06
K251799Mobility 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