Cleared Traditional

K851256 - MOBIE SCOOTER

K851256 is the FDA 510(k) clearance for MOBIE SCOOTER by Everest & Jennings, Inc.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K851256 · Everest & Jennings, Inc. · Physical Medicine device
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Jun 1985
Decision
92d
Days
Class 2
Risk

K851256 is an FDA 510(k) clearance for the MOBIE SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 92 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 Everest & Jennings, Inc. devices

Submission Details

510(k) Number K851256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1985
Decision Date June 28, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.