Cleared Traditional

K851256 - MOBIE SCOOTER

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

K851256 · Everest & Jennings, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K851256

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 116d · This submission: 92d
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 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K851256.
ALPHA SUPER KART
K853766 · Alpha Unlimited, Inc. · Nov 1985
ALL TERRAIN AMIGO
K852557 · Amigo Sales, Inc. · Aug 1985
SPARROW MOTORIZED SCOOTER
K852380 · Venturego, Inc. · Aug 1985
ALPHA TRI-KART
K841919 · Alpha Unlimited, Inc. · May 1984
PORTASCOOT POWER SEAT
K840866 · E.F. Brewer Co. · Mar 1984
PACESAVER & SCOUT
K834506 · Burke, Inc. · Jan 1984
K851256 · MOBIE SCOOTER
Download PDF Everest & Jennings, I…