Cleared Traditional

K230001 - Electric Scooter (Model: M2020)

K230001 is an FDA 510(k) clearance for Electric Scooter (Model: M2020), 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 183-day FDA review.

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

FDA 510(k) Submission Details - K230001

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.

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 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