Cleared Special

MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V

K091113 · Pride Mobility Products Corp. · Physical Medicine
May 2009
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K091113 is an FDA 510(k) clearance for the MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on May 11, 2009, 24 days after receiving the submission on April 17, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K091113 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2009
Decision Date May 11, 2009
Days to Decision 24 days
Submission Type Special
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
Power Mobility Scooter (MJMA01, MJMA02)
K253936 · Nanjing Mijo Technology Co., Ltd. · Mar 2026
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