Cleared Traditional

Mobility Scooter (BC-MS310)

K252817 · Ningbo Baichen Medical Devices Co., Ltd. · Physical Medicine
Jan 2026
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K252817 is an FDA 510(k) clearance for the Mobility Scooter (BC-MS310), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Ningbo Baichen Medical Devices Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on January 2, 2026, 120 days after receiving the submission on September 4, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K252817 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 2025
Decision Date January 02, 2026
Days to Decision 120 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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