Cleared Special

K011107 - MODIFICATION TO SOLO

K011107 is an FDA 510(k) clearance for MODIFICATION TO SOLO, manufactured by Ranger All Season Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Special 510(k) pathway after a 28-day FDA review.

K011107 · Ranger All Season Corp. · Physical Medicine device
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May 2001
Decision
28d
Days
Class 2
Risk

K011107 is an FDA 510(k) clearance for the MODIFICATION TO SOLO. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Ranger All Season Corp. (George, US). The FDA issued a Cleared decision on May 14, 2001 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ranger All Season Corp. devices

FDA 510(k) Submission Details - K011107

510(k) Number K011107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 14, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 163
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K011107.
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