Cleared Traditional

Solax Electric Scooter (Model: S202261B) (K202549) - FDA 510(k) Clearance

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

K202549 · Dongguan Prestige Sporting Goods Co., Ltd. · Physical Medicine device
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Feb 2021
Decision
176d
Days
Class 2
Risk

K202549 is an FDA 510(k) clearance for the Solax Electric Scooter (Model: S202261B). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Dongguan Prestige Sporting Goods Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on February 26, 2021 after a review of 176 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 Dongguan Prestige Sporting Goods Co., Ltd. devices

Submission Details

510(k) Number K202549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2020
Decision Date February 26, 2021
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
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

Guangzhou GLOMED Biological Technology Co., 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 79
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K202549.
Scooter (Model: FDB01)
K201196 · Nanjing Jin Bai HE Medical Apparatus Co., Ltd. · Jun 2021
Solax Electric Scooter (Models: S204311M, S204161, S204143)
K190737 · Dongguan Prestige Sporting Goods Co., Ltd. · May 2021
Solax Electric Scooter
K192190 · Dongguan Prestige Sporting Goods Co., Ltd. · Apr 2021
Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)
K191897 · Dongguan Prestige Sporting Goods Co., Ltd. · Feb 2021
Wu's Electrical Scooter
K192308 · Wu'S Tech Co., Ltd. · Dec 2020
C.T.M. Mobility Scooter HS-268
K192885 · Chien TI Enterprise Co., Ltd. · Dec 2019