Cleared Traditional

K853766 - ALPHA SUPER KART

K853766 is an FDA 510(k) clearance for ALPHA SUPER KART, manufactured by Alpha Unlimited, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K853766 · Alpha Unlimited, Inc. · Physical Medicine device
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Nov 1985
Decision
72d
Days
Class 2
Risk

K853766 is an FDA 510(k) clearance for the ALPHA SUPER KART. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Alpha Unlimited, Inc. (Sarasota, US). The FDA issued a Cleared decision on November 20, 1985 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alpha Unlimited, Inc. devices

FDA 510(k) Submission Details - K853766

510(k) Number K853766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date November 20, 1985
Days to Decision 72 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
43d faster than avg
Panel avg: 115d · This submission: 72d
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 247
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K853766.
FORTRESS 2000FS 3-WHEEL SCOOTER
K895693 · Fortress Scientific , Ltd. · Oct 1989
FORTRESS MODEL 2200FS FRONT WHEEL DRIVE SCOOTER
K895694 · Fortress Scientific , Ltd. · Oct 1989
CARRETTE 3 WHEELED MOTORIZED CART
K891609 · Everest & Jennings, Inc. · Apr 1989
MOBIE SCOOTER
K851256 · Everest & Jennings, Inc. · Jun 1985
MOBIE
K832727 · Everest & Jennings, Inc. · Sep 1983