Cleared Traditional

K010503 - AMIGO WHEELCHAIR

K010503 is an FDA 510(k) clearance for AMIGO WHEELCHAIR, manufactured by Amigo Mobility Intl., Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K010503 · Amigo Mobility Intl., Inc. · Physical Medicine device
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Jul 2001
Decision
135d
Days
Class 2
Risk

K010503 is an FDA 510(k) clearance for the AMIGO WHEELCHAIR. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Amigo Mobility Intl., Inc. (Bridgeport, US). The FDA issued a Cleared decision on July 6, 2001 after a review of 135 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.

FDA 510(k) Submission Details - K010503

510(k) Number K010503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2001
Decision Date July 06, 2001
Days to Decision 135 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
19d slower than avg
Panel avg: 116d · This submission: 135d
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 332
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K010503.
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SAFARI
K010606 · Ranger All Season Corp. · Mar 2001
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K010503 · AMIGO WHEELCHAIR
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