Cleared Traditional

K924515 - ELECTRIC MOBILITY RASCAL

K924515 is an FDA 510(k) clearance for ELECTRIC MOBILITY RASCAL, manufactured by Electric Mobility Corp.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 570-day FDA review.

K924515 · Electric Mobility Corp. · Physical Medicine device
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Mar 1994
Decision
570d
Days
Class 2
Risk

K924515 is an FDA 510(k) clearance for the ELECTRIC MOBILITY RASCAL. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Electric Mobility Corp. (Sewell, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 570 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K924515

510(k) Number K924515 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 04, 1992
Decision Date March 28, 1994
Days to Decision 570 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
454d slower than avg
Panel avg: 116d · This submission: 570d
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 Consultant

Electric Mobility, LLC
Jordan Flowers

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

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K924515 · ELECTRIC MOBILITY RASCAL
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