Cleared Traditional

Electric Scooter (Model: M2020)

K230001 · Guangdong Prestige Technology Co., Ltd. · Physical Medicine
Jul 2023
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K230001 is an FDA 510(k) clearance for the Electric Scooter (Model: M2020), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Guangdong Prestige Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 5, 2023, 183 days after receiving the submission on January 3, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K230001 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2023
Decision Date July 05, 2023
Days to Decision 183 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

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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