Cleared Traditional

Power Mobility Scooter (MJMA01, MJMA02)

K253936 · Nanjing Mijo Technology Co., Ltd. · Physical Medicine
Mar 2026
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K253936 is an FDA 510(k) clearance for the Power Mobility Scooter (MJMA01, MJMA02), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Nanjing Mijo Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 12, 2026, 93 days after receiving the submission on December 9, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K253936 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2025
Decision Date March 12, 2026
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code INI — Vehicle, Motorized 3-wheeled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3800

Similar Devices — INI Vehicle, Motorized 3-wheeled

All 341
Mobility Scooter (CL-Q3, CL-Q4)
K253631 · Zhejiang Wei Ling New Energy Technology Co., Ltd. · Feb 2026
Mobility Scooter (S3)
K253643 · Shenzhen Zhimahuaerkai Technology Co., Ltd. · Feb 2026
Electric Scooter (DDF100)
K252275 · Zhejiang Nysin Medical Co., Ltd. · Jan 2026
Electric Scooter (Mojo-T580)
K252347 · Dongguan Smarfody Mobility Technology Co., Ltd. · Jan 2026
Electric Scooter (Mojo-T330)
K252349 · Dongguan Smarfody Mobility Technology Co., Ltd. · Jan 2026
Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
K253075 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jan 2026