Cleared Traditional

Scooter, Model: R-100 (K182411) - FDA 510(k) Clearance

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

K182411 · Yongkang Dingchang Industry & Trade Co., Ltd. · Physical Medicine device
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Jun 2019
Decision
293d
Days
Class 2
Risk

K182411 is an FDA 510(k) clearance for the Scooter, Model: R-100. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Yongkang Dingchang Industry & Trade Co., Ltd. (Yongkang, CN). The FDA issued a Cleared decision on June 24, 2019 after a review of 293 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 Yongkang Dingchang Industry & Trade Co., Ltd. devices

Submission Details

510(k) Number K182411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date June 24, 2019
Days to Decision 293 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
178d slower than avg
Panel avg: 115d · This submission: 293d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 77
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K182411.
C.T.M. Mobility Scooter HS-268
K192885 · Chien TI Enterprise Co., Ltd. · Dec 2019
SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)
K182631 · Eurogreen International, Inc. · Sep 2019
Scooter
K182471 · Tianjin Kepler Vehicle Industry Co. , Ltd. · Jul 2019
C.T.M Mobility Scooter
K181344 · Chien TI Enterprise Co., Ltd. · Dec 2018
Solax Electric Scooter, Models: S302121, S302131, S302141, S302151
K172440 · Dongguan Prestige Sporting Goods., Ltd. · Jul 2018
Lite
K172409 · Tzora Active Systems , Ltd. · May 2018