Cleared Traditional

Electric Scooter (DDF100)

K252275 · Zhejiang Nysin Medical Co., Ltd. · Physical Medicine
Jan 2026
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K252275 is an FDA 510(k) clearance for the Electric Scooter (DDF100), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Zhejiang Nysin Medical Co., Ltd. (Jinhua, CN). The FDA issued a Cleared decision on January 29, 2026, 191 days after receiving the submission on July 22, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K252275 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2025
Decision Date January 29, 2026
Days to Decision 191 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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