Cleared Traditional

K971050 - GOLDEN HAWK

K971050 is an FDA 510(k) clearance for GOLDEN HAWK, manufactured by Golden Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K971050 · Golden Technologies, Inc. · Physical Medicine device
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Aug 1997
Decision
133d
Days
Class 2
Risk

K971050 is an FDA 510(k) clearance for the GOLDEN HAWK. 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 August 1, 1997 after a review of 133 days - within the typical 510(k) review window.

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 Golden Technologies, Inc. devices

FDA 510(k) Submission Details - K971050

510(k) Number K971050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1997
Decision Date August 01, 1997
Days to Decision 133 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 240
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K971050.
AMIGO RT
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GOLDEN EAGLE
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FREERIDER, MODEL FR510-F
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FREERIDER, MODEL FR168-4
K971388 · Freerider USA, Inc. · Jul 1997
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
K965123 · Burke, Inc. · Jul 1997