Cleared Special

K041025 - BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED

K041025 is an FDA 510(k) clearance for BUZZAROUND, 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 12-day FDA review.

K041025 · Golden Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
12d
Days
Class 2
Risk

K041025 is an FDA 510(k) clearance for the BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED. 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 May 3, 2004 after a review of 12 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 Golden Technologies, Inc. devices

FDA 510(k) Submission Details - K041025

510(k) Number K041025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2004
Decision Date May 03, 2004
Days to Decision 12 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 115d · This submission: 12d
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 241
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K041025.
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MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
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