Cleared Traditional

K133187 - FREERIDER FR1

K133187 is an FDA 510(k) clearance for FREERIDER FR1, manufactured by Freerider Corp. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K133187 · Freerider Corp · Physical Medicine device
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Jan 2015
Decision
448d
Days
Class 2
Risk

K133187 is an FDA 510(k) clearance for the FREERIDER FR1, models FR1-13, FR1-15, FR1-17. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Freerider Corp (Rancho Cucamonga, US). The FDA issued a Cleared decision on January 8, 2015 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Freerider Corp devices

FDA 510(k) Submission Details - K133187

510(k) Number K133187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date January 08, 2015
Days to Decision 448 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 115d · This submission: 448d
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 146
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