Cleared Traditional

K182631 - SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

K182631 is an FDA 510(k) clearance for SupaScoota Motorized vehicle - Spartan ..., manufactured by Eurogreen International, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K182631 · Eurogreen International, Inc. · Physical Medicine device
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Sep 2019
Decision
360d
Days
Class 2
Risk

K182631 is an FDA 510(k) clearance for the SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Eurogreen International, Inc. (Chang-Hua County, CN). The FDA issued a Cleared decision on September 19, 2019 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Eurogreen International, Inc. devices

FDA 510(k) Submission Details - K182631

510(k) Number K182631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2018
Decision Date September 19, 2019
Days to Decision 360 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
245d slower than avg
Panel avg: 115d · This submission: 360d
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 Peers - INI Vehicle, Motorized 3-wheeled

All 209
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