Cleared Special

V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710

K090805 · Pride Mobility Products Corp. · Physical Medicine
Apr 2009
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K090805 is an FDA 510(k) clearance for the V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710, 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 April 3, 2009, 9 days after receiving the submission on March 25, 2009. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K090805 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2009
Decision Date April 03, 2009
Days to Decision 9 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