Cleared Traditional

K011476 - SOVEREIGN

K011476 is an FDA 510(k) clearance for SOVEREIGN, manufactured by Shoprider Intl., Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K011476 · Shoprider Intl., Inc. · Physical Medicine device
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Oct 2001
Decision
169d
Days
Class 2
Risk

K011476 is an FDA 510(k) clearance for the SOVEREIGN. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Shoprider Intl., Inc. (Neodesha, US). The FDA issued a Cleared decision on October 30, 2001 after a review of 169 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.

FDA 510(k) Submission Details - K011476

510(k) Number K011476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date October 30, 2001
Days to Decision 169 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
53d slower than avg
Panel avg: 116d · This submission: 169d
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 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K011476.
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K012792 · Warepalmy Enterprise, LLC (Usa) · Oct 2001
EASYTRAVEL
K012592 · Tzora Active Systems , Ltd. · Oct 2001
K011476 · SOVEREIGN
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