Cleared Traditional

K954378 - FORMULA IV ELECTRIC MOBILITY VEHICLE

K954378 is an FDA 510(k) clearance for FORMULA IV ELECTRIC MOBILITY VEHICLE, manufactured by Aerotek. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K954378 · Aerotek · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
310d
Days
Class 2
Risk

K954378 is an FDA 510(k) clearance for the FORMULA IV ELECTRIC MOBILITY VEHICLE. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Aerotek (Renfrew, Ontario, CA). The FDA issued a Cleared decision on July 25, 1996 after a review of 310 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Aerotek devices

FDA 510(k) Submission Details - K954378

510(k) Number K954378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1995
Decision Date July 25, 1996
Days to Decision 310 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
195d slower than avg
Panel avg: 115d · This submission: 310d
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 213
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K954378.
BOOSTER TROPHY 5 MOTORIZED SCOOTER
K955275 · Optimed Technologies, Inc. · Nov 1996
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K955276 · Optimed Technologies, Inc. · Nov 1996
PILLAR 4-WHEEL SCOOTER
K961888 · Pillar Technology, Inc. · Oct 1996
PACE SAVER LITTLE JUNIOR (MODIFICATION)
K954974 · Burke Mobility Products · Mar 1996
TRAVEL EASE ELECTRIC SCOOTER, MODEL: PIONEER
K952042 · Merits Health Products Co., Ltd. · Mar 1996
EURO SC500
K944940 · Pride Health Care, Inc. · Feb 1996