Cleared Traditional

K240272 - Electric Scooter (M2085

K240272 is an FDA 510(k) clearance for Electric Scooter (M2085, manufactured by Guangdong Prestige Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K240272 · Guangdong Prestige Technology Co., Ltd. · Physical Medicine device
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Jul 2024
Decision
167d
Days
Class 2
Risk

K240272 is an FDA 510(k) clearance for the Electric Scooter (M2085, S2091). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Guangdong Prestige Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 16, 2024 after a review of 167 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 Guangdong Prestige Technology Co., Ltd. devices

FDA 510(k) Submission Details - K240272

510(k) Number K240272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2024
Decision Date July 16, 2024
Days to Decision 167 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
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

Share Info (Guangzhou) Medical Consultant , Ltd.
Lee Cassie

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
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