Cleared Traditional

K222729 - Electrical Scooter, WT-T4QP2

K222729 is an FDA 510(k) clearance for Electrical Scooter, manufactured by Wu'S Tech Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K222729 · Wu'S Tech Co., Ltd. · Physical Medicine device
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Mar 2023
Decision
201d
Days
Class 2
Risk

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

Submitted by Wu'S Tech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on March 28, 2023 after a review of 201 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Wu'S Tech Co., Ltd. devices

FDA 510(k) Submission Details - K222729

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 115d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Chinese European Industrial Research Society
Dr.Jen Ke-Min

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 209
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K222729.
Electric Scooter (Model: M2020)
K230001 · Guangdong Prestige Technology Co., Ltd. · Jul 2023
ATTO Mobility Scooter (ATTO)
K222703 · Moving Life, Ltd. · May 2023
Electric Scooter (Model: S3312)
K230615 · Guangdong Prestige Technology Co., Ltd. · May 2023
Mobility Scooter (Models: W3431Q, W3431R)
K222507 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Feb 2023
eFOLDi Scooter, Lite
K223492 · Suntech UK , Ltd. · Feb 2023
HS186B Scooter
K222711 · Suzhou Master Machinery Manufacturing Co.,Ltd · Jan 2023