Cleared Abbreviated

PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER (K031897) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K031897 · Imc-Heart Way LLC · Physical Medicine device
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Sep 2003
Decision
96d
Days
Class 2
Risk

K031897 is an FDA 510(k) clearance for the PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Imc-Heart Way LLC (Fort Myers, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 96 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Imc-Heart Way LLC devices

Submission Details

510(k) Number K031897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2003
Decision Date September 23, 2003
Days to Decision 96 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 345
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