Cleared Traditional

K240590 - Electrical Scooter

K240590 is an FDA 510(k) clearance for Electrical Scooter, manufactured by W'U'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 313-day FDA review.

K240590 · W'U'S Tech Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
313d
Days
Class 2
Risk

K240590 is an FDA 510(k) clearance for the Electrical Scooter, WT-T4SU. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by W'U'S Tech Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on January 8, 2025 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 W'U'S Tech Co., Ltd. devices

FDA 510(k) Submission Details - K240590

510(k) Number K240590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2024
Decision Date January 08, 2025
Days to Decision 313 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
198d slower than avg
Panel avg: 115d · This submission: 313d
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

Wu’S Tech Co., Ltd.
Ke-Min Jen

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 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K240590.
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