Cleared Traditional

K253936 - Power Mobility Scooter (MJMA01, MJMA02) (FDA 510(k) Clearance)

Mar 2026
Decision
93d
Days
Class 2
Risk

K253936 is an FDA 510(k) clearance for the Power Mobility Scooter (MJMA01, MJMA02). This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).

Submitted by Nanjing Mijo Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 12, 2026, 93 days after receiving the submission on December 9, 2025.

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

Submission Details

510(k) Number K253936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2025
Decision Date March 12, 2026
Days to Decision 93 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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