Cleared Traditional

K252835 - Electric Scooter (S202572J

K252835 is an FDA 510(k) clearance for Electric Scooter (S202572J, 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 109-day FDA review.

K252835 · Guangdong Prestige Technology Co., Ltd. · Physical Medicine device
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Dec 2025
Decision
109d
Days
Class 2
Risk

K252835 is an FDA 510(k) clearance for the Electric Scooter (S202572J, S2060, M2089, S2050). 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 December 23, 2025 after a review of 109 days - within the typical 510(k) review window.

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 - K252835

510(k) Number K252835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2025
Decision Date December 23, 2025
Days to Decision 109 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
6d faster than avg
Panel avg: 115d · This submission: 109d
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.
Cassie Lee

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 K252835.
Electric Scooter (Mojo-T330)
K252349 · Dongguan Smarfody Mobility Technology Co., Ltd. · Jan 2026
Mobility scooter (Air Classic)
K253075 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jan 2026
Mobility Scooter (BC-MS310)
K252817 · Ningbo Baichen Medical Devices Co., Ltd. · Jan 2026
Mobility Scooter (T5)
K252588 · Zhejiang Taotao Vehicle Co., Ltd. · Dec 2025
Powered Mobility Scooter (PMS105, GUT177, GCAT047)
K252590 · Intradin (Shanghai) Machinery Co., Ltd. · Nov 2025
Folding Mobility Scooter (KD101)
K252502 · Nanjing Kangni Smart Technology Co., Ltd. · Oct 2025