Cleared Traditional

Mobility Scooter (CL-Q3, CL-Q4)

Feb 2026
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K253631 is an FDA 510(k) clearance for the Mobility Scooter (CL-Q3, CL-Q4), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Zhejiang Wei Ling New Energy Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on February 23, 2026, 96 days after receiving the submission on November 19, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K253631 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2025
Decision Date February 23, 2026
Days to Decision 96 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

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