Cleared Traditional

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

Jan 2026
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K253075 is an FDA 510(k) clearance for the Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0), a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on January 9, 2026, 108 days after receiving the submission on September 23, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K253075 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2025
Decision Date January 09, 2026
Days to Decision 108 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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