Cleared Special

K063162 - GOLDEN LITEWAY

K063162 is an FDA 510(k) clearance for GOLDEN LITEWAY, manufactured by Golden Technologies, Inc.. 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.

K063162 · Golden Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
15d
Days
Class 2
Risk

K063162 is an FDA 510(k) clearance for the GOLDEN LITEWAY. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Golden Technologies, Inc. (Old Forge, US). The FDA issued a Cleared decision on November 2, 2006 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 - K063162

510(k) Number K063162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2006
Decision Date November 02, 2006
Days to Decision 15 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
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 354
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K063162 · GOLDEN LITEWAY
Download PDF FDA Summary Golden Technologies, …