Cleared Traditional

K880425 - STERLING (MOTORIZED VEHICLE)

K880425 is the FDA 510(k) clearance for STERLING (MOTORIZED VEHICLE) by A-Bec Mobility, Inc.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K880425 · A-Bec Mobility, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
15d
Days
Class 2
Risk

K880425 is an FDA 510(k) clearance for the STERLING (MOTORIZED VEHICLE). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by A-Bec Mobility, Inc. (Torrance, US). The FDA issued a Cleared decision on February 16, 1988 after a review of 15 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 A-Bec Mobility, Inc. devices

Submission Details

510(k) Number K880425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date February 16, 1988
Days to Decision 15 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
100d faster than avg
Panel avg: 115d · This submission: 15d
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.