Cleared Special

K010606 - SAFARI

K010606 is an FDA 510(k) clearance for SAFARI, 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 15-day FDA review.

K010606 · Ranger All Season Corp. · Physical Medicine device
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Mar 2001
Decision
15d
Days
Class 2
Risk

K010606 is an FDA 510(k) clearance for the SAFARI. 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 March 16, 2001 after a review of 15 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.

FDA 510(k) Submission Details - K010606

510(k) Number K010606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2001
Decision Date March 16, 2001
Days to Decision 15 days
Submission Type Special
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
101d faster than avg
Panel avg: 116d · This submission: 15d
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 332
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K010606.
RAMBLER
K011401 · Rambler Mobility, Inc. · Jul 2001
AMIGO WHEELCHAIR
K010503 · Amigo Mobility Intl., Inc. · Jul 2001
MODIFICATION TO SOLO
K011107 · Ranger All Season Corp. · May 2001
LASER 3 SPSC300
K003058 · Pride Mobility Products Corp. · Mar 2001
LASER 4SPSC340
K003059 · Pride Mobility Products Corp. · Mar 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
K010606 · SAFARI
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