Cleared Traditional

K253075 - Mobility scooter (Air Classic) (FDA 510(k) Clearance)

Also includes:
Mobility scooter (Air Traveller) Mobility scooter (Air Traveller2.0)
Jan 2026
Decision
108d
Days
Class 2
Risk

K253075 is an FDA 510(k) clearance for the Mobility scooter (Air Classic). This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.3800.

Submission Details

510(k) Number K253075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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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