Cleared Traditional

K222729 - Electrical Scooter, WT-T4QP2 (FDA 510(k) Clearance)

Mar 2023
Decision
201d
Days
Class 2
Risk

K222729 is an FDA 510(k) clearance for the Electrical Scooter, WT-T4QP2. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).

Submitted by Wu'S Tech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on March 28, 2023, 201 days after receiving the submission on September 8, 2022.

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

Submission Details

510(k) Number K222729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2022
Decision Date March 28, 2023
Days to Decision 201 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