Cleared Traditional

K252588 - Mobility Scooter (T5) (FDA 510(k) Clearance)

Dec 2025
Decision
111d
Days
Class 2
Risk

K252588 is an FDA 510(k) clearance for the Mobility Scooter (T5). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).

Submitted by Zhejiang Taotao Vehicle Co., Ltd. (Lishui, CN). The FDA issued a Cleared decision on December 4, 2025, 111 days after receiving the submission on August 15, 2025.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K252588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2025
Decision Date December 04, 2025
Days to Decision 111 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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