Cleared Traditional

K970646 - SAFARI

K970646 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 Traditional 510(k) pathway after a 195-day FDA review.

K970646 · Ranger All Season Corp. · Physical Medicine device
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Aug 1997
Decision
195d
Days
Class 2
Risk

K970646 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 August 25, 1997 after a review of 195 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.

View all Ranger All Season Corp. devices

FDA 510(k) Submission Details - K970646

510(k) Number K970646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date August 25, 1997
Days to Decision 195 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
80d slower than avg
Panel avg: 115d · This submission: 195d
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 162
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K970646.
ACTIVA
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