Cleared Traditional

J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT (K022518) - FDA 510(k) Clearance

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

K022518 · Roc Chinese-European Industrial Research Society · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
125d
Days
Class 2
Risk

K022518 is an FDA 510(k) clearance for the J.P. 3-WHEELED SCOOTER, ES-350 CITYBUG II/ RABBIT. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Roc Chinese-European Industrial Research Society (Columbus, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 125 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 Roc Chinese-European Industrial Research Society devices

Submission Details

510(k) Number K022518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2002
Decision Date December 02, 2002
Days to Decision 125 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
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 Peers - INI Vehicle, Motorized 3-wheeled

All 345
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K022518.
Scooter (YD-03)
K253600 · Yurob Rehabilitation Medical Co., Ltd. · Jun 2026
Mobility Scooter (Air Carbon)
K260717 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · May 2026
Mobility Scooter (X-12, X-14, X-17)
K260237 · Wuyi Aichi Industry and Trade Co., Ltd. · Apr 2026
Electrical Scooter (SM4226)
K252813 · Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. · Mar 2026
Power Mobility Scooter (MJMA01, MJMA02)
K253936 · Nanjing Mijo Technology Co., Ltd. · Mar 2026
Mobility Scooter (CL-Q3, CL-Q4)
K253631 · Zhejiang Wei Ling New Energy Technology Co., Ltd. · Feb 2026