Cleared Traditional

K192308 - Wu's Electrical Scooter (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192308 · Wu'S Tech Co., Ltd. · Physical Medicine device
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Dec 2020
Decision
483d
Days
Class 2
Risk

K192308 is an FDA 510(k) clearance for the Wu's Electrical Scooter. 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 December 21, 2020 after a review of 483 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

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

Submission Details

510(k) Number K192308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2019
Decision Date December 21, 2020
Days to Decision 483 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
368d slower than avg
Panel avg: 115d · This submission: 483d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
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 343
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K192308.
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