Cleared Traditional

Electric Scooter (Model: M2020) (K230001) - FDA 510(k) Clearance

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

K230001 · Guangdong Prestige Technology Co., Ltd. · Physical Medicine device
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Jul 2023
Decision
183d
Days
Class 2
Risk

K230001 is an FDA 510(k) clearance for the Electric Scooter (Model: M2020). 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 5, 2023 after a review of 183 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

Submission Details

510(k) Number K230001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2023
Decision Date July 05, 2023
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
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

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 74
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K230001.
Mobility Scooter (C4+)
K234098 · Yongkang Yile Vehicle Co., Ltd. · Apr 2024
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K231472 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jul 2023
Mobility Scooter (Models: W3431D)
K231428 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jul 2023
ATTO Mobility Scooter (ATTO)
K222703 · Moving Life, Ltd. · May 2023
Electric Scooter (Model: S3312)
K230615 · Guangdong Prestige Technology Co., Ltd. · May 2023
Electrical Scooter, WT-T4QP2
K222729 · Wu'S Tech Co., Ltd. · Mar 2023