Cleared Traditional

K972038 - INTRUDER

K972038 is an FDA 510(k) clearance for INTRUDER, manufactured by The Buzzz Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K972038 · The Buzzz Corp. · Physical Medicine device
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Jul 1997
Decision
31d
Days
Class 2
Risk

K972038 is an FDA 510(k) clearance for the INTRUDER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by The Buzzz Corp. (Larksville, US). The FDA issued a Cleared decision on July 3, 1997 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Buzzz Corp. devices

FDA 510(k) Submission Details - K972038

510(k) Number K972038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date July 03, 1997
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
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 K972038.
PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
K965123 · Burke, Inc. · Jul 1997
STEALTH
K972036 · The Buzzz Corp. · Jul 1997
PROWLER
K972037 · The Buzzz Corp. · Jul 1997
SOLO
K970523 · Ranger All Season Corp. · Jun 1997
SUPERLIGHT
K964954 · Wheelcare Scooters, Inc. · Mar 1997
TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
K952042 · Merits Health Products Co., Ltd. · Mar 1996