Cleared Abbreviated

K090966 - AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGORY V HEAVY DUTY 3 WHEEL (650000)

K090966 is an FDA 510(k) clearance for AMIGO CATEGORY III FULL-SIZED REGULAR D..., manufactured by Svrc Industries, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Abbreviated 510(k) pathway after a 39-day FDA review.

K090966 · Svrc Industries, Inc. · Physical Medicine device
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May 2009
Decision
39d
Days
Class 2
Risk

K090966 is an FDA 510(k) clearance for the AMIGO CATEGORY III FULL-SIZED REGULAR DUTY 3 WHEEL (310000) AND AMIGO CATEGOR.... Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Svrc Industries, Inc. (Saginaw, US). The FDA issued a Cleared decision on May 15, 2009 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Svrc Industries, Inc. devices

FDA 510(k) Submission Details - K090966

510(k) Number K090966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date May 15, 2009
Days to Decision 39 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

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 171
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