Cleared Traditional

Mobility Scooter (MS160C)

K251638 · Suzhou Master Machinery Manufacturing Co.,Ltd · Physical Medicine
Jul 2025
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K251638 is an FDA 510(k) clearance for the Mobility Scooter (MS160C), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Suzhou Master Machinery Manufacturing Co.,Ltd (Kunshan, CN). The FDA issued a Cleared decision on July 22, 2025, 54 days after receiving the submission on May 29, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K251638 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date July 22, 2025
Days to Decision 54 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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